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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78763

65 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 07, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

65 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 65

Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM

Z-0420-2018
Recall number
Z-0420-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814311180, Lot No. 459190, Exp. Date 05/17/2027, (01)00887868038082 (17)270517 (10)459190

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 2 of 65

Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM

Z-0421-2018
Recall number
Z-0421-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309180, Lot No. 459250, Exp. Date 05/27/2027, UDI (01)00887868037962 (17)270527 (10)459250

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 3 of 65

Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM

Z-0422-2018
Recall number
Z-0422-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511180, Lot No. 459170, Exp. Date 05/18/2027, (01)00887868039102 (17)270518 (10)459170

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 4 of 65

Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM

Z-0423-2018
Recall number
Z-0423-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509180, Lot No. 459290, Exp. Date 05/17/2027, (01)00887868038846 (17)270517 (10)459290

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 5 of 65

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM

Z-0424-2018
Recall number
Z-0424-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814411320; Lot No. (Exp. Date) UDI: 459230 (05/19/2027) UDI (01)00887868038464 (17)270519 (10)459230, 701830 (06/03/2027) UDI (01)00887868038464 (17)270603 (10)701830, 893480 (06/12/2027) UDI (01) 00887868038464 (17)270612 (10)893480

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 6 of 65

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM

Z-0425-2018
Recall number
Z-0425-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814411360; Lot No. 935900; Exp. Date 06/15/2027, UDI (01)00887868038488 (17)270615 (10)935900

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 7 of 65

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM

Z-0426-2018
Recall number
Z-0426-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814411440; Lot No. 459240; Exp. Date 05/21/2027, UDI (01)00887868038525 (17)270521 (10)459240

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 8 of 65

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM

Z-0427-2018
Recall number
Z-0427-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814409260; Lot No. 936020; Exp. Date 06/15/2027, UDI (01)00887868038327 (17)270615 (10)936020

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 9 of 65

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM

Z-0428-2018
Recall number
Z-0428-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814409340; Lot No. (Exp. Date) UDI: 581630 (06/03/2027 UDI (01)00887868038365 (17)270603 (10)581630; 942020 (06/16/2027) UDI (01)00887868038365 (17)270616 (10)942020

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 10 of 65

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM

Z-0429-2018
Recall number
Z-0429-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814409380; Lot No. (Exp. Date) UDI: 398590 (05/19/2027 UDI (01)00887868038389 (17)270519 (10)398590; 702190 (06/04/2027) UDI (01)00887868038389 (17)270604 (10)702190

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 11 of 65

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM

Z-0430-2018
Recall number
Z-0430-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814409440; Lot No. (Exp. Date) UDI: 936140 (06/15/2027 UDI (01)00887868038419 (17)270615 (10)936140

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 12 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM

Z-0431-2018
Recall number
Z-0431-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611260; Lot No. (Exp. Date) UDI: 507350 (05/21/2027 UDI (01)00887868039768 (17)270521 (10)507350; 701700 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701700; 701720 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701720; 701780 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701780

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 13 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM

Z-0432-2018
Recall number
Z-0432-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611280; Lot No. (Exp. Date) UDI: 459270 (05/18/2027) UDI (01)00887868039775 (17)270518 (10)459270; 858780 (06/16/2027) UDI (01)00887868039775 (17)270616 (10)858780; 972840 (06/15/2027) UDI (01)00887868039775 (17)270615 (10)972840

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 14 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM

Z-0433-2018
Recall number
Z-0433-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 81461130; Lot No. (Exp. Date) UDI: 406280 (05/19/2027) UDI (01)00887868039782 (17)270519 (10)406280; 972900 (06/16/2027) UDI (01)00887868039782 (17)270616 (10)972900

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 15 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM

Z-0434-2018
Recall number
Z-0434-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611340; Lot No. (Exp. Date) UDI: 535240 (05/24/2027) UDI (01)00887868039805 (17)270524 (10)535240

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 16 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM

Z-0435-2018
Recall number
Z-0435-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611380; Lot No. (Exp. Date) UDI: 555730 (05/24/2027) UDI (01)00887868039829 (17)270524 (10)555730

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 17 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM

Z-0436-2018
Recall number
Z-0436-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611400; Lot No. (Exp. Date) UDI: 582380 (05/29/2027) UDI (01)00887868039836 (17)270529 (10)582380; 702230 (06/04/2027) UDI (01)00887868039836 (17)270604 (10)702230

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 18 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM

Z-0437-2018
Recall number
Z-0437-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611420; Lot No. (Exp. Date) UDI: 535690 (05/30/2027) UDI (01)00887868039843 (17)270530 (10)535690

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 19 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM

Z-0438-2018
Recall number
Z-0438-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611440; Lot No. (Exp. Date) UDI: 858840 (06/14/2027) UDI (01)00887868039850 (17)270614 (10)858840

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 20 of 65

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM

Z-0439-2018
Recall number
Z-0439-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814611460; Lot No. (Exp. Date) UDI: 555810 (05/27/2027) UDI (01)00887868039867 (17)270527 (10)555810; 788580 (07/17/2027) UDI (01)00887868039867 (17)270717 (10)788580

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 21 of 65

Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM

Z-0440-2018
Recall number
Z-0440-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814613460; Lot No. (Exp. Date) UDI: 862150 (06/15/2027) UDI (01)00887868039980 (17)270615 (10)862150

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 22 of 65

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM

Z-0441-2018
Recall number
Z-0441-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814609280; Lot No. (Exp. Date) UDI: 936100 (06/15/2027) UDI (01)00887868039669 (17)270615 (10)936100

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 23 of 65

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM

Z-0442-2018
Recall number
Z-0442-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814609300; Lot No. (Exp. Date) UDI: 595480 (05/28/2027) UDI (01)00887868039676 (17)270528 (10)595480; 788380 (06/15/2027) UDI (01)00887868039676 (17)270615 (10)788380; 973000 (07/10/2027) UDI (01)00887868039676 (17)270710 (10)973000

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 24 of 65

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM

Z-0443-2018
Recall number
Z-0443-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814609320; Lot No. (Exp. Date) UDI: 535150 (05/24/2027) UDI (01)00887868039683 (17)270524 (10)535150; 942050 (06/15/2027) UDI (01)00887868039683 (17)270615 (10)942050

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 25 of 65

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM

Z-0444-2018
Recall number
Z-0444-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814609340; Lot No. (Exp. Date) UDI: 535230 (05/24/2027) UDI (01)00887868039690 (17)270524 (10)535230

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 26 of 65

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM

Z-0445-2018
Recall number
Z-0445-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814609400; Lot No. (Exp. Date) UDI: 480330 (05/19/2027) UDI (01)00887868039720 (17)270519 (10)480330; 701940 (06/03/2027) UDI (01)00887868039720 (17)270603 (10)701940; 858970 (06/14/2027) UDI (01)00887868039720 (17)270614 (10)858970

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 27 of 65

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM

Z-0446-2018
Recall number
Z-0446-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814609420; Lot No. (Exp. Date) UDI: 438040 (05/22/2027) UDI (01)00887868039737 (17)270522 (10)438040; 701640 (06/04/2027) UDI (01)00887868039737 (17)270604 (10)701640

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 28 of 65

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM

Z-0447-2018
Recall number
Z-0447-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814609440; Lot No. (Exp. Date) UDI: 507340 (05/22/2027) UDI (01)00887868039744 (17)270522 (10)507340; 858900 (06/14/2027) UDI (01)00887868039744 (17)270614 (10)858900

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 29 of 65

Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM

Z-0448-2018
Recall number
Z-0448-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814344300; Lot No. (Exp. Date) UDI: 459160 (05/18/2027) UDI (01)00887868038112 (17)270518 (10)459160; 893470 (06/16/2027) UDI (01)00887868038112 (17)270616 (10)893470

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 30 of 65

Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM

Z-0449-2018
Recall number
Z-0449-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814311380; Lot No. (Exp. Date) UDI: 459200 (05/18/2027) UDI (01)00887868038150 (17)270518 (10)459200

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 31 of 65

Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM

Z-0450-2018
Recall number
Z-0450-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814311440; Lot No. (Exp. Date) UDI: 666800 (06/16/2027) UDI (01)00887868038181 (17)270616 (10)666800

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 32 of 65

Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM

Z-0451-2018
Recall number
Z-0451-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814311460; Lot No. (Exp. Date) UDI: 788650 (06/05/2027) UDI (01)00887868038198 (17)270605 (10)788650

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 33 of 65

Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM

Z-0452-2018
Recall number
Z-0452-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814313260; Lot No. (Exp. Date) UDI: 760270 (06/12/2027) UDI (01)00887868038211 (17)270612 (10)760270

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 34 of 65

Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM

Z-0453-2018
Recall number
Z-0453-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814313320; Lot No. (Exp. Date) UDI: 788630 (06/05/2027) UDI (01)00887868038242 (17)270605 (10)788630

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 35 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM

Z-0454-2018
Recall number
Z-0454-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309260; Lot No. (Exp. Date) UDI: 702050 (06/12/2027) UDI (01)00887868037979 (17)270612 (10)702050

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 36 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM

Z-0455-2018
Recall number
Z-0455-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309320; Lot No. (Exp. Date) UDI: 669850 (06/15/2027) UDI (01)00887868038006 (17)270615 (10)669850; 737670 (06/14/2027) UDI (01)00887868038006 (17)270614 (10)737670

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 37 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM

Z-0456-2018
Recall number
Z-0456-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309340; Lot No. (Exp. Date) UDI: 581620 (05/26/2027) UDI (01)00887868038013 (17)270526 (10)581620

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 38 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM

Z-0457-2018
Recall number
Z-0457-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309360; Lot No. (Exp. Date) UDI: 788440 (06/15/2027) UDI (01)00887868038020 (17)270615 (10)788440; 788460 (06/07/2027) UDI (01)00887868038020 (17)270607 (10)788460

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 39 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM

Z-0458-2018
Recall number
Z-0458-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309400; Lot No. (Exp. Date) UDI: 437960 (05/20/2027) UDI (01)00887868038044 (17)270520 (10)437960; 893070 (06/14/2027) UDI (01)00887868038044 (17)270614 (10)893070

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 40 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM

Z-0459-2018
Recall number
Z-0459-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309420; Lot No. (Exp. Date) UDI: 935970 (06/15/2027) UDI (01)00887868038051 (17)270615 (10)935970

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 41 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM

Z-0460-2018
Recall number
Z-0460-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309440; Lot No. (Exp. Date) UDI: 760030 (06/14/2027) UDI (01)00887868038068 (17)270614 (10)760030; 788620 (06/07/2027) UDI (01)00887868038068 (17)270607 (10)788620

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 42 of 65

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM

Z-0461-2018
Recall number
Z-0461-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814309460; Lot No. (Exp. Date) UDI: 737630 (06/14/2027) UDI (01)00887868038075 (17)270614 (10)737630

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 43 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM

Z-0462-2018
Recall number
Z-0462-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511260; Lot No. (Exp. Date) UDI: 512520 (05/20/2027) UDI (01)00887868039119 (17)270520 (10)512520; 701810 (06/05/2027) UDI (01)00887868039119 (17)270605 (10)701810; 893460 (06/15/2027) UDI (01)00887868039119 (17)270615 (10)893460

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 44 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM

Z-0463-2018
Recall number
Z-0463-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511280 ; Lot No. (Exp. Date) UDI: 893430 (06/15/2027) UDI (01)00887868039126 (17)270615 (10)893430; 893490 (06/15/2027) UDI (01)00887868039126 (17)270615 (10)893490

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 45 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM

Z-0464-2018
Recall number
Z-0464-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511300; Lot No. (Exp. Date) UDI: 480070 (06/12/2027) UDI (01)00887868039133 (17)270612 (10)480070; 858790 (06/12/2027) UDI (01)00887868039133 (17)270612 (10)858790; 893450 (06/15/2027) UDI (01)00887868039133 (17)270615 (10)893450

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 46 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM

Z-0465-2018
Recall number
Z-0465-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511320; Lot No. (Exp. Date) UDI: 480090 (05/18/2027) UDI (01)00887868039140 (17)270518 (10)480090; 893410 (06/12/2027) UDI (01)00887868039140 (17)270612 (10)893410; 942070 (07/17/2027) UDI (01)00887868039140 (17)270717 (10)942070

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 47 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM

Z-0466-2018
Recall number
Z-0466-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511340; Lot No. (Exp. Date) UDI: 581910 (05/25/2027) UDI (01)00887868039157 (17)270525 (10)581910

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 48 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM

Z-0467-2018
Recall number
Z-0467-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511360; Lot No. (Exp. Date) UDI: 555620 (05/24/2027) UDI (01)00887868039164 (17)270524 (10)555620

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 49 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM

Z-0468-2018
Recall number
Z-0468-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511360; Lot No. (Exp. Date) UDI: 862170 (06/16/2027) UDI (01)00887868039171 (17)270616 (10)862170

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 50 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM

Z-0469-2018
Recall number
Z-0469-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511400; Lot No. (Exp. Date) UDI: 507300 (05/21/2027) UDI (01)00887868039188 (17)270521 (10)507300

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 51 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM

Z-0470-2018
Recall number
Z-0470-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511420; Lot No. (Exp. Date) UDI: 535130 (06/02/2027) UDI (01)00887868039195 (17)270602 (10)535130; 858960 (06/15/2027) UDI (01)00887868039195 (17)270615 (10)858960

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 52 of 65

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM

Z-0471-2018
Recall number
Z-0471-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814511440; Lot No. (Exp. Date) UDI: 507320 (05/21/2027) UDI (01)00887868039201 (17)270521 (10)507320

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 53 of 65

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM

Z-0472-2018
Recall number
Z-0472-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814513280; Lot No. (Exp. Date) UDI: 581960 (05/31/2027) UDI (01)00887868039263 (17)270531 (10)581960; 858740 (06/26/2027) UDI (01)00887868039263 (17)270626 (10)858740

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 54 of 65

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM

Z-0473-2018
Recall number
Z-0473-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814513300; Lot No. (Exp. Date) UDI: 581970 (06/01/2027) UDI (01)00887868039270 (17)270601 (10)581970; 942010 (06/24/2027) UDI (01)00887868039270 (17)270624 (10)942010

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 55 of 65

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM

Z-0474-2018
Recall number
Z-0474-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814513440; Lot No. (Exp. Date) UDI: 582240 (05/27/2027) UDI (01)00887868039348 (17)270527 (10)582240

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 56 of 65

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM

Z-0475-2018
Recall number
Z-0475-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814513460; Lot No. (Exp. Date) UDI: 582360 (05/26/2027) UDI (01)00887868039355 (17)270526 (10)582360

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 57 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM

Z-0476-2018
Recall number
Z-0476-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509260; Lot No. (Exp. Date) UDI: 581640 (05/27/2027) UDI (01)00887868038853 (17)270527 (10)581640; 788410 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)788410; 892940 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892940; 892950 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892950

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 58 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM

Z-0477-2018
Recall number
Z-0477-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509300; Lot No. (Exp. Date) UDI: 581700 (05/27/2027) UDI (01)00887868038877 (17)270527 (10)581700

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 59 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM

Z-0478-2018
Recall number
Z-0478-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509320; Lot No. (Exp. Date) UDI: 555180 (05/24/2027) UDI (01)00887868038884 (17)270524 (10)555180; 858640 (06/15/2027) UDI (01)00887868038884 (17)270615 (10)858640; 893090 (06/12/2027) UDI (01)00887868038884 (17)270612 (10)893090

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 60 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM

Z-0479-2018
Recall number
Z-0479-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509340; Lot No. (Exp. Date) UDI: 535120 (05/24/2027) UDI (01)00887868038891 (17)270524 (10)535120; 893500 (06/12/2027) UDI (01)00887868038891 (17)270612 (10)893500

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 61 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM

Z-0480-2018
Recall number
Z-0480-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509360; Lot No. (Exp. Date) UDI: 555460 (05/24/2027) UDI (01)00887868038907 (17)270524 (10)555460; 892960 (06/14/2027) UDI (01)00887868038907 (17)270614 (10)892960; 892990 (06/15/2027) UDI (01)00887868038907 (17)270615 (10)892990

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 62 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM

Z-0481-2018
Recall number
Z-0481-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509380; Lot No. (Exp. Date) UDI: 507130 (05/21/2027) UDI (01)00887868038914 (17)270521 (10)507130; 892880 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)892880; 893400 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)893400

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 63 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM

Z-0482-2018
Recall number
Z-0482-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509400; Lot No. (Exp. Date) UDI: 480050 (05/21/2027) UDI (01)00887868038921 (17)270521 (10)480050; 701480 (06/03/2027) UDI (01)00887868038921 (17)270603 (10)701480; 701900 (06/03/2027) UDI (01)00887868038921 (17)270603 (10)701900

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 64 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM

Z-0483-2018
Recall number
Z-0483-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509420; Lot No. (Exp. Date) UDI: 398610 (05/19/2027) UDI (01)00887868038938 (17)270519 (10)398610; 858830 (06/13/2027) UDI (01)00887868038938 (17)270613 (10)858830; 858930 (06/13/2027) UDI (01)00887868038938 (17)270613 (10)858930

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.

device · product 65 of 65

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM

Z-0484-2018
Recall number
Z-0484-2018
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Code information

Item No. 814509440; Lot No. (Exp. Date) UDI: 438020 (05/18/2027) UDI (01)00887868038945 (17)270518 (10)438020

Distribution pattern

US nationwide distribution. Also Portugal and the Netherlands.