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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93323

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

Open FDA event record

Event summary

Timeline bucket
October 09, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
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

19 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 19

Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400

Z-0370-2024
Recall number
Z-0370-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 541470 (01)00880304259690(17)270629(10)541470 608490 (01)00880304259690(17)280302(10)608490 608580 (01)00880304259690(17)271030(10)608580 609140 (01)00880304259690(17)271112(10)609140 671410 (01)00880304259690(17)271030(10)671410 671650 (01)00880304259690(17)271030(10)671650 856920 (01)00880304259690(17)271030(10)856920

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 2 of 19

Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402

Z-0371-2024
Recall number
Z-0371-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 240750 (01)00880304259713(17)270112(10)240750 671330 (01)00880304259713(17)271114(10)671330 671420 (01)00880304259713(17)270831(10)671420 671660 (01)00880304259713(17)270901(10)671660 752730 (01)00880304259713(17)270802(10)752730 752760 (01)00880304259713(17)270816(10)752760 798010 (01)00880304259713(17)270120(10)798010 921660 (01)00880304259713(17)270724(10)921660 930670 (01)00880304259713(17)270727(10)930670 930680 (01)00880304259713(17)270802(10)930680 965330 (01)00880304259713(17)271112(10)965330

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 3 of 19

Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404

Z-0372-2024
Recall number
Z-0372-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 017900 (01)00880304002890(17)270912(10)017900; 017900R (01)00880304002890(17)270912(10)017900R; 240760 (01)00880304002890(17)270120(10)240760; 332020 (01)00880304002890(17)270725(10)332020; 332040 (01)00880304002890(17)270629(10)332040; 608500 (01)00880304002890(17)270830(10)608500; 608590 (01)00880304002890(17)271030(10)608590; 609150 (01)00880304002890(17)270830(10)609150; 671670 (01)00880304002890(17)271030(10)671670; 712220 (01)00880304002890(17)270114(10)712220; 752770 (01)00880304002890(17)270814(10)752770; 798020 (01)0 0880304002890(17)270120(10)798020; 965310 (01)00880304002890(17)271112(10)965310,

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 4 of 19

Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406

Z-0373-2024
Recall number
Z-0373-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 018050 (01)00880304259744(17)270807(10)018050; 018050R (01)00880304259744(17)270807(10)018050R; 056160 (01)00880304259744(17)270108(10)056160; 332030 (01)00880304259744(17)270702(10)332030; 332050 (01)00880304259744(17)270710(10)332050; 608510 (01)00880304259744(17)270924(10)608510; 608600 (01)00880304259744(17)271026(10)608600; 671730 (01)00880304259744(17)270831(10)671730; 752780 (01)00880304259744(17)270817(10)752780;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 5 of 19

Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178408

Z-0374-2024
Recall number
Z-0374-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 017910 (01)00880304259768(17)270807(10)017910; 017910R (01)00880304259768(17)270807(10)017910R; 018060 (01)00880304259768(17)270817(10)018060; 332060 (01)00880304259768(17)270817(10)332060; 608610 (01)00880304259768(17)271204(10)608610; 671740 (01)00880304259768(17)271117(10)671740; 671740R (01)00880304259768(17)271117(10)671740R; 752790 (01)00880304259768(17)270816(10)752790; 752790R (01)00880304259768(17)270816(10)752790R; 965290 (01)00880304259768(17)271030(10)965290;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 6 of 19

Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410

Z-0375-2024
Recall number
Z-0375-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 332070 (01)00880304259782(17)270812(10)332070; 608620 (01)00880304259782(17)271113(10)608620; 671750 (01)00880304259782(17)271115(10)671750; 752800 (01)00880304259782(17)270816(10)752800; 856930 (01)00880304259782(17)271030(10)856930; 856930R (01)00880304259782(17)271030(10)856930R; 930690 (01)00880304259782(17)270630(10)930690;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 7 of 19

Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412

Z-0376-2024
Recall number
Z-0376-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 332080 (01)00880304259805(17)270706(10)332080; 671760 (01)00880304259805(17)271026(10)671760; 752810 (01)00880304259805(17)270725(10)752810; 856940 (01)00880304259805(17)271030(10)856940; 930700 (01)00880304259805(17)270816(10)930700

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 8 of 19

Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414

Z-0377-2024
Recall number
Z-0377-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 017930 (01)00880304259829(17)270702(10)017930; 018070 (01)00880304259829(17)270629(10)018070; 608560 (01)00880304259829(17)271030(10)608560 752820 (01)00880304259829(17)280222(10)752820 752830 (01)00880304259829(17)270817(10)752830

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 9 of 19

Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552

Z-0378-2024
Recall number
Z-0378-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 331640 (01)00880304461659(17)270726(10)331640; 331660 (01)00880304461659(17)270629(10)331660; 331670 (01)00880304461659(17)270726(10)331670; 477980 (01)00880304461659(17)280112(10)477980; 577330 (01)00880304461659(17)270725(10)577330; 577640 (01)00880304461659(17)270816(10)577640; 608520 (01)00880304461659(17)271030(10)608520; 608530 (01)00880304461659(17)280112(10)608530; 608630 (01)00880304461659(17)271204(10)608630; 671430 (01)00880304461659(17)271204(10)671430; 671810 (01)00880304461659(17)271117(10)671810; 735610 (01)00880304461659(17)271209(10)735610; 735960 (01)00880304461659(17)271202(10)735960; 795170 (01)00880304461659(17)290305(10)795170; 856960 (01)00880304461659(17)271115(10)856960; 930720 (01)00880304461659(17)270703(10)930720; 975150 (01)00880304461659(17)270731(10)975150; 982350 (01)00880304461659(17)270723(10)982350;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 10 of 19

Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554

Z-0379-2024
Recall number
Z-0379-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI 331680 (01)00880304461703(17)270726(10)331680; 331690 (01)00880304461703(17)270806(10)331690; 331700 (01)00880304461703(17)270726(10)331700; 331700R (01)00880304461703(17)270726(10)331700R; 541430 (01)00880304461703(17)271119(10)541430; 577340 (01)00880304461703(17)280112(10)577340; 577340R (01)00880304461703(17)280112(10)577340R; 577660 (01)00880304461703(17)270630(10)577660; 608640 (01)00880304461703(17)271030(10)608640; 671450 (01)00880304461703(17)271030(10)671450; 671820 (01)00880304461703(17)270830(10)671820; 712430 (01)00880304461703(17)271111(10)712430; 735640 (01)00880304461703(17)271031(10)735640; 735660 (01)00880304461703(17)280416(10)735660; 856970 (01)00880304461703(17)280212(10)856970; 930730 (01)00880304461703(17)271030(10)930730;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 11 of 19

Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556

Z-0380-2024
Recall number
Z-0380-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 331710 (01)00880304461635(17)270702(10)331710; 331720 (01)00880304461635(17)270723(10)331720; 331730 (01)00880304461635(17)270629(10)331730; 331740 (01)00880304461635(17)270726(10)331740; 477990 (01)00880304461635(17)270820(10)477990; 541450 (01)00880304461635(17)270725(10)541450; 577360 (01)00880304461635(17)270801(10)577360; 577690 (01)00880304461635(17)270814(10)577690; 577700 (01)00880304461635(17)270725(10)577700; 608540 (01)00880304461635(17)270902(10)608540; 608650 (01)00880304461635(17)271030(10)608650; 608670 (01)00880304461635(17)271030(10)608670; 671830 (01)00880304461635(17)270901(10)671830; 829350 (01)00880304461635(17)270823(10)829350

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 12 of 19

Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558

Z-0381-2024
Recall number
Z-0381-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 331750 (01)00880304461673(17)270726(10)331750; 331760 (01)00880304461673(17)270725(10)331760; 331770 (01)00880304461673(17)270901(10)331770; 577380 (01)00880304461673(17)270725(10)577380; 608690 (01)00880304461673(17)271030(10)608690; 671340 (01)00880304461673(17)271026(10)671340; 671350 (01)00880304461673(17)271127(10)671350; 671460 (01)00880304461673(17)271030(10)671460; 671840 (01)00880304461673(17)271117(10)671840; 735690 (01)00880304461673(17)271030(10)735690; 735720 (01)00880304461673(17)271109(10)735720; 735720R (01)00880304461673(17)271109(10)735720R; 930750 (01)00880304461673(17)270726(10)930750

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 13 of 19

Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560

Z-0382-2024
Recall number
Z-0382-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 331780 (01)00880304461680(17)270709(10)331780; 331790 (01)00880304461680(17)270726(10)331790; 331810 (01)00880304461680(17)270703(10)331810; 507020 (01)00880304461680(17)270724(10)507020; 507020R (01)00880304461680(17)270724(10)507020R; 608550 (01)00880304461680(17)271103(10)608550; 608700 (01)00880304461680(17)271030(10)608700; 671490 (01)00880304461680(17)271117(10)671490; 671850 (01)00880304461680(17)271102(10)671850; 857020 (01)00880304461680(17)271117(10)857020

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 14 of 19

Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562

Z-0383-2024
Recall number
Z-0383-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 331820 (01)00880304461666(17)270710(10)331820; 478000 (01)00880304461666(17)270629(10)478000; 535420 (01)00880304461666(17)270826(10)535420; 608710 (01)00880304461666(17)271114(10)608710; 608740 (01)00880304461666(17)271113(10)608740; 671500 (01)00880304461666(17)271030(10)671500; 671510 (01)00880304461666(17)280121(10)671510; 857040 (01)00880304461666(17)271112(10)857040;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 15 of 19

Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564

Z-0384-2024
Recall number
Z-0384-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 441020 (01)00880304461628(17)270915(10)441020; 535430 (01)00880304461628(17)270701(10)535430; 577560 (01)00880304461628(17)270725(10)577560; 577740 (01)00880304461628(17)271114(10)577740; 608760 (01)00880304461628(17)271112(10)608760; 671870 (01)00880304461628(17)280131(10)671870; 975160 (01)00880304461628(17)270806(10)975160

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 16 of 19

Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565

Z-0385-2024
Recall number
Z-0385-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 930790 (01)00880304528697(17)270709(10)930790

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 17 of 19

Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566

Z-0386-2024
Recall number
Z-0386-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 535440 (01)00880304461642(17)270803(10)535440; 577570 (01)00880304461642(17)270726(10)577570; 577590 (01)00880304461642(17)270802(10)577590; 608770 (01)00880304461642(17)280201(10)608770; 671520 (01)00880304461642(17)280131(10)671520; 671530 (01)00880304461642(17)271026(10)671530; 671880 (01)00880304461642(17)271114(10)671880; 671880R (01)00880304461642(17)271114(10)671880R; 735750 (01)00880304461642(17)271102(10)735750; 735750R (01)00880304461642(17)271102(10)735750R; 965240 (01)00880304461642(17)280113(10)965240

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 18 of 19

Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568

Z-0387-2024
Recall number
Z-0387-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 535450 (01)00880304461611(17)270727(10)535450; 577600 (01)00880304461611(17)270630(10)577600; 577610 (01)00880304461611(17)270702(10)577610; 577760 (01)00880304461611(17)270629(10)577760; 671540 (01)00880304461611(17)271124(10)671540; 671890 (01)00880304461611(17)271114(10)671890; 671890R (01)00880304461611(17)271114(10)671890R; 857060 (01)00880304461611(17)280324(10)857060; 930770 (01)00880304461611(17)270725(10)930770

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

device · product 19 of 19

Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570

Z-0388-2024
Recall number
Z-0388-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information

Lot Numbers/UDI: 178570 (01)00880304461697(17)270811(10)535460; 535460R (01)00880304461697(17)270811(10)535460R; 671550 (01)00880304461697(17)271124(10)671550

Distribution pattern

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.