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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Biomet, Inc.: Biomet Compress Device Anchor Plugs Recalled for Potential Metal Burrs

Agency Publication Date: November 21, 2023
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Summary

Biomet, Inc. is recalling various sizes of its Compress Device Segmental and Short Anchor Plugs because they may contain metal burrs within the device's holes. These burrs can prevent surgical tools or pins from passing through the device during implantation, which can lead to complications or the extension of surgery time while the patient is under anesthesia. These medical devices are used specifically for correcting or revising unsuccessful joint replacements or bone surgeries.

Risk

The presence of metal fragments (burrs) can block necessary surgical instruments like drills or pins from functioning correctly during a procedure. This defect may result in extended surgical time, potential tissue irritation, or the need for surgeons to use alternative devices mid-operation.

What You Should Do

  1. Check your surgical inventory for Compress Device Segmental Anchor Plugs (10mm to 24mm) or Short Anchor Plugs (10mm to 28mm) with Item Numbers ranging from 178400 to 178570.
  2. Verify the Lot Numbers and UDI codes on the product packaging against the affected list, which includes hundreds of specific codes such as Lot 541470 (UDI 01008803042596901727062910541470) and Lot 965240 (UDI 01008803044616421728011310965240).
  3. Immediately stop using and quarantine any affected anchor plugs to ensure they are not used in upcoming surgical procedures.
  4. Contact your Biomet, Inc. representative or the manufacturer directly at 56 E Bell Dr, Warsaw, Indiana, to arrange for the return of affected products and to receive further technical instructions.
  5. If you are a patient who has recently undergone a joint revision or osteotomy surgery, contact your surgeon or healthcare provider to discuss any concerns regarding the implants used.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Compress Device Segmental Anchor Plug, 10 MM
Model / REF:
178400
UPC Codes:
00880304259690
Lot Numbers:
541470
608490
608580
609140
671410
671650
856920
Product: Compress Device Segmental Anchor Plug, 12 MM
Model / REF:
178402
UPC Codes:
00880304259713
Lot Numbers:
240750
671330
671420
671660
752730
752760
798010
921660
930670
930680
965330
Product: Compress Device Segmental Anchor Plug, 14 MM
Model / REF:
178404
UPC Codes:
00880304002890
Lot Numbers:
017900
017900R
240760
332020
332040
608500
608590
609150
671670
712220
752770
798020
965310
Product: Compress Device Segmental Anchor Plug, 16 MM
Model / REF:
178406
UPC Codes:
00880304259744
Lot Numbers:
018050
018050R
056160
332030
332050
608510
608600
671730
752780
Product: Compress Device Segmental Anchor Plug, 18 MM
Model / REF:
178408
UPC Codes:
00880304259768
Lot Numbers:
017910
017910R
018060
332060
608610
671740
671740R
752790
752790R
965290
Product: Compress Device Segmental Anchor Plug, 20 MM
Model / REF:
178410
UPC Codes:
00880304259782
Lot Numbers:
332070
608620
671750
752800
856930
856930R
930690
Product: Compress Device Segmental Anchor Plug, 22 MM
Model / REF:
178412
UPC Codes:
00880304259805
Lot Numbers:
332080
671760
752810
856940
930700
Product: Compress Device Segmental Anchor Plug, 24 MM
Model / REF:
178414
UPC Codes:
00880304259829
Lot Numbers:
017930
018070
608560
752820
752830
Product: Compress Device Short Anchor Plug, 10 MM
Model / REF:
178552
UPC Codes:
00880304461659
Lot Numbers:
331640
331660
331670
477980
577330
577640
608520
608530
608630
671430
671810
735610
735960
795170
856960
930720
975150
982350
Product: Compress Device Short Anchor Plug, 12 MM
Model / REF:
178554
UPC Codes:
00880304461703
Lot Numbers:
331680
331690
331700
331700R
541430
577340
577340R
577660
608640
671450
671820
712430
735640
735660
856970
930730
Product: Compress Device Short Anchor Plug, 14 MM
Model / REF:
178556
UPC Codes:
00880304461635
Lot Numbers:
331710
331720
331730
331740
477990
541450
577360
577690
577700
608540
608650
608670
671830
829350
Product: Compress Device Short Anchor Plug, 16 MM
Model / REF:
178558
UPC Codes:
00880304461673
Lot Numbers:
331750
331760
331770
577380
608690
671340
671350
671460
671840
735690
735720
735720R
930750
Product: Compress Device Short Anchor Plug, 18 MM
Model / REF:
178560
UPC Codes:
00880304461680
Lot Numbers:
331780
331790
331810
507020
507020R
608550
608700
671490
671850
857020
Product: Compress Device Short Anchor Plug, 20 MM
Model / REF:
178562
UPC Codes:
00880304461666
Lot Numbers:
331820
478000
535420
608710
608740
671500
671510
857040
Product: Compress Device Short Anchor Plug, 22 MM
Model / REF:
178564
UPC Codes:
00880304461628
Lot Numbers:
441020
535430
577560
577740
608760
671870
975160
Product: Compress Device Short Anchor Plug, 23 MM
Model / REF:
178565
UPC Codes:
00880304528697
Lot Numbers:
930790
Product: Compress Device Short Anchor Plug, 24 MM
Model / REF:
178566
UPC Codes:
00880304461642
Lot Numbers:
535440
577570
577590
608770
671520
671530
671880
671880R
735750
735750R
965240
Product: Compress Device Short Anchor Plug, 26 MM
Model / REF:
178568
UPC Codes:
00880304461611
Lot Numbers:
535450
577600
577610
577760
671540
671890
671890R
857060
930770
Product: Compress Device Short Anchor Plug, 28 MM
Model / REF:
178570
UPC Codes:
00880304461697
Lot Numbers:
535460
535460R
671550

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93323
Status: Active
Manufacturer: Biomet, Inc.
Sold By: Authorized Medical Distributors; Hospitals; Surgical Centers
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.