Reported Nov 15, 2023 · Ongoing
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
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?
- RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm
- REF509-01-436, orthopedic shoulder implant component
- Lot codes and dates
- UDI-DI00888912144667
- Lot390P1157
- Amount recalled
- 20
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
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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