Arthrex recalls titanium tibial plates with confused part numbers that could lead to incorrect use in bone treatments. Affected items have specific part and lot codes.
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Arthrex is recalling titanium tibial plates that were mistakenly labeled with the wrong part number. This confusion could lead to improper use during bone surgery, potentially causing complications.
The part number was confused between AR-13200T-15.0 and AR-13200ST-15.0 during manufacturing. This mix-up could lead to using the wrong plate size or type in surgery, which might cause improper bone healing.
Surgical patients receiving this specific plate for bone treatment are affected. Surgeons and medical facilities using the recalled part numbers are most at risk.
Check for part number AR-13200T-15.0 or lot code 12135408 on the plate. The product is used for treating non-union, mal-union, and fractures of the tibia and femur.
Verify the part number on the plate is AR-13200T-15.0 or AR-13200ST-15.0.
Using the wrong part number could lead to incorrect surgical application, potentially causing improper bone healing.
The official recall notice does not specify a remedy for this part number mix-up.
The recall affects only the specific part numbers and lot codes mentioned; it does not impact all surgeries.
We’ve drafted a message you can send Arthrex to request your refund or repair — edit it as you like.
Subject: Recall Z-1380-2021 — Arthrex Arthrex Hello, I own a Arthrex that is covered by recall Z-1380-2021 from Arthrex. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.