CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
Compress Device Short Anchor Plug-For Correction recalled by Biomet
Biomet is recalling Compress Device Short Anchor Plug-For Correction of revision of unsuccessful osteotomy, distributed nationwide in the US. The recall was initiated on 9 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0388-2024
- FDA event ID
- 93323
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2023
- FDA classified
- 21 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 9 Oct 2023 | Recall initiated by company | |
| 21 Nov 2023 | Classified by FDA | +43 days |
| 29 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
Where it was distributed
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot Numbers/UDI: 178570 (01)00880304461697(17)270811(10)535460; 535460R (01)00880304461697(17)270811(10)535460R; 671550 (01)00880304461697(17)271124(10)671550
Where was it sold?
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 93323This product is part of a recall event; the main page for the event is Compress Device Short Anchor Plug-For Correction recalled by Biomet.
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