Reported Sep 21, 2022 · Ongoing
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers
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?
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers
15 of 15 products
| Model / number | Product as published |
|---|---|
144-28-05 | 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID |
144-28-06 | 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID |
144-28-07 | 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID |
144-28-08 | 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID |
144-28-09 | 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID |
144-28-10 | 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID |
146-28-04 | 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID |
146-28-05 | 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID |
146-32-06 | 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID |
144-32-05 | O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID |
144-32-06 | O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID |
144-32-07 | O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID |
144-32-08 | O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID |
144-32-09 | O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID |
144-32-10 | O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID |
- Amount recalled
- 1017 devices
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Exactech, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.