Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with
3 of 3 products
| Model / number | Product as published |
|---|---|
314-13-13 | 47, 50, 53 head, Medium |
314-13-14 | 47, 50, 53 head, Large |
314-13-15 | 47, 50, 53 head, Extra Large, ; Shoulder Arthroplasty |
- Lot codes and dates
a) Item Number 314-13-13UDI/DI 10885862172693
- Serial Numbers
3,615 of 3,615 codes
220482022048122204813220481524521782500820249963823310722427399233106422048302336229242739322048312204818233624423362532336241242739724273872499624249963225008032336258233624523362572406667240667324274042427392246006424066532499640233107823362492336235220482125008182204827233106222048242204822233106823310742406665240666424066582452182240665025008042452181246005724066632406649249962523362542427402233623022048292204825
- Amount recalled
- 12643 units
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
This product could cause temporary or reversible health problems — stop using it.
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