FX SHOULDER recalls Centered Glenosphere w/Screw models with possible eccentric glenosphere. Affected units have UDI-DI: 03701037309551, Lot: U0191. No remedy specified.
Centered glenosphere box may contain an eccentric glenosphere.
FX SHOULDER is recalling certain Centered Glenosphere w/Screw implants that may contain an eccentric glenosphere. This could cause improper joint function or movement. The recall affects specific model numbers with UDI-DI: 03701037309551 and Lot: U0191.
The recall states that the centered glenosphere box may contain an eccentric glenosphere. This means the implant could be misaligned or not function properly, potentially causing joint issues or movement problems.
Patients who received the recalled Centered Glenosphere w/Screw implants with UDI-DI: 03701037309551 and Lot: U0191 are most at risk. The recall applies to individuals who have this specific implant model.
Check for the UDI-DI code 03701037309551 and Lot number U0191 on the implant packaging or label. The product is identified as Centered Glenosphere w/Screw with CoCr/TA6V/TiN 10-degrees Tilt 32 mm.
Look for UDI-DI: 03701037309551 and Lot: U0191 on the implant packaging or label.
The recall record does not specify any remedy.
Check the UDI-DI code and lot number on the implant packaging. If it matches 03701037309551 and U0191, contact FX SHOULDER for further instructions.
The affected implants have UDI-DI: 03701037309551 and Lot: U0191. Check the packaging or label for these identifiers.
We’ve drafted a message you can send FX SHOULDER to request your refund or repair — edit it as you like.
Subject: Recall Z-0843-2024 — FX SHOULDER FX SHOULDER Hello, I own a FX SHOULDER that is covered by recall Z-0843-2024 from FX SHOULDER. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.