Smith & Nephew recalls OSTEORAPTOR 2.9 absorbable suture anchors with incomplete sterile packaging that could breach sterility during surgery.
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Smith & Nephew is recalling OSTEORAPTOR 2.9 absorbable suture anchors due to potential packaging failures that might compromise sterility during surgery. This could lead to infections if the sterile barrier is breached.
The packaging may not seal properly, creating a breach in the sterile barrier. This could allow contamination during surgical procedures, potentially leading to infections.
Orthopedic surgeons and medical professionals using the OSTEORAPTOR 2.9 suture anchors. Patients undergoing surgery with this device are at risk if the packaging is compromised.
Check for product number 72201994 and batch numbers listed in the recall (2012769, 2013999, 2016154, 2021495, 2023224, 2025101, 2026924, 2027418, 2029364, 2030912, 2030913, 2033496, 2036691, 2049654, 2053758, 2050886).
Inspect the pouch for signs of improper sealing before use.
The recall indicates potential packaging issues that could compromise sterility, so it's recommended to check packaging integrity before use.
Batch numbers 2012769, 2013999, 2016154, 2021495, 2023224, 2025101, 2026924, 2027418, 2029364, 2030912, 2030913, 2033496, 2036691, 2049654, 2053758, 2050886.
The recall does not specify a return process, so check with your supplier or manufacturer for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0151-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0151-2021 from Smith & Nephew. 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.
