Reported Feb 7, 2024 · Ongoing
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Fx Shoulder
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: FX SHOULDER · 13465 Midway Rd Ste 310 · Dallas, TX · 75244-5183
Is this the product you have?
- Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm
- REF115-3210
- Lot codes and dates
- UDI-DI03701037309551
- LotU0191
- Amount recalled
- 4
Where it was sold
- Nationwide
- NJ
Why it was recalled
Centered glenosphere box may contain an eccentric glenosphere.
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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