Reported Sep 27, 2023 · Ongoing
DJO Surgical
Encore Medical, LP
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: Encore Medical, LP · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
DJO Surgical
3 of 3 products
| Model / number | Product as published |
|---|---|
508-01-032 | Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm |
508-32-104 | Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm |
508-36-101 | Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm |
- Lot codes and dates
- REF/UDI-DI/Lot/Expiration
508-01-032/00888912024693/859C1190/April 292027508-32-104/00888912024754/866C3153/May 252029 and 866C3147/April 32029508-36-101/869C3539/April 302028
- REF/UDI-DI/Lot/Expiration
- Amount recalled
- 64
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
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 Encore Medical, LP 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.