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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84224

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

Open FDA event record

Event summary

Timeline bucket
October 25, 2019
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

2 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 2

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

Z-0594-2020
Recall number
Z-0594-2020
Initiated
October 25, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

Code information

Lot Numbers: 025800, 025810, 081640 UDI: (01)00880304386570(17)280202(10)025800 (01)00880304386570(17)280205(10)025810 (01)00880304386570(17)280524(10)081640

Distribution pattern

Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand

device · product 2 of 2

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

Z-0595-2020
Recall number
Z-0595-2020
Initiated
October 25, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

Code information

Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670

Distribution pattern

Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand