Smith & Nephew recalls OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE absorbable suture anchors with improper sterile pouch seals. This could breach the sterile barrier during use, risking infection. Affected units include specific batch numbers from 2012-2029.
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 certain OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE absorbable suture anchors due to a potential breach in the sterile packaging. If the pouch seal is compromised, the surgical product could become contaminated, increasing infection risk during procedures.
The packaging pouch may not seal properly, allowing contaminants to enter the sterile product. This could lead to infection if the suture anchor is used in surgery without a clean, intact sterile barrier.
Surgical professionals and patients who received the recalled OSTEORAPTOR suture anchors with specific batch numbers from 2012 to 2029. Those using the product in procedures are most at risk of infection if the sterile barrier is compromised.
Check the product label for the batch numbers listed: 2012935, 2013910, 2016229, 2017812, 2018635, 2019990, 2021454, 2022268, 2024711, 2025147, 2027400, 2029394, 2030945, 2037184, 2038460, 2038795, 2039253, 2039444, 2045859, 2045858, 2045860, 2045861, 2048368, 2049884, 2048367. The product is an absorbable suture anchor sold under the OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE name.
Look for the batch numbers listed in the recall notice to determine if your product is affected.
The recall indicates a potential risk of contamination if the sterile pouch seal is compromised. Affected units should be checked for proper sealing before use.
The recall does not specify a remedy. Check the product label for batch numbers to see if it is affected. If affected, contact Smith & Nephew for guidance.
Check the product label for batch numbers: 2012935, 2013910, 2016229, 2017812, 2018635, 2019990, 2021454, 2022268, 2024711, 2025147, 2027400, 2029394, 2030945, 2037184, 2038460, 2038795, 2039253, 2039444, 2045859, 2045858, 2045860, 2045861, 2048368, 2049884, 2048367.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0165-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0165-2021 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.
