Reported Jul 28, 2021 · Ongoing
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX,…
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 Connexion GXL acetabular polyethylene
- liners used in the following systemsCatalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene
- liners used in the following systemsCatalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene
- liners used in the following systemsCatalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component
- Lot codes and dates
- All serial numbers
- UDI-DI numbers
138-32-XX: 1088586202473210885862024749108858620247561088586202476310885862024770. 138-36-XX: 1088586202481710885862024824108858620248311088586202484810885862024886108858620248931088586202490910885862024916. 138-40-XX: 108858622088041088586220881110885862208828
- Amount recalled
- 89,050 total
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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