Synthes recalls LCP One-Third Tubular Plates with potential reduced screw locking strength due to dimensional tolerance issues. Affected plates may not hold securely in fractures.
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
Synthes is recalling certain trauma plates that might not hold screws securely, which could lead to fractures shifting. This is a safety issue for people using these plates for bone repairs.
The plates may have thread pitch, diameter, or depth measurements slightly off. This could cause screws to not lock properly into the bone, potentially shifting the fracture site.
People who own or use the recalled LCP One-Third Tubular Plates for bone fixation are affected. Those with osteopenic bone (weaker bone) may be at higher risk.
Check for the part number 241.381 and lot number 29P6036 on the plate. The product is intended for fixing fractures in bones like the clavicle or pelvis.
Look for part number 241.381 and lot number 29P6036 on the plate.
The plates may have dimensional features out of tolerance, which could reduce screw locking strength and cause fractures to shift.
The recall record does not specify a remedy, so check with Synthes for further instructions.
The recall indicates a potential risk of reduced screw locking strength, but the product is generally safe if used correctly.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-2816-2020 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-2816-2020 from Synthes. 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.
