Smith & Nephew recalls OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK absorbable suture anchors with improper sterile pouch seals. This could breach the sterile barrier 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 absorbable suture anchors that may have improper sterile packaging seals. If the pouch isn't sealed correctly, the surgical site could become contaminated during procedures.
The pouch surrounding the sterile suture anchor may not seal properly. This could allow contamination during surgery if the packaging is breached, but the device itself is still safe for use.
Surgical patients and medical professionals using these suture anchors for procedures. The risk is low as the issue is with packaging, not the device itself.
Check for product number 72203291 and batch numbers 2012936, 2013911, 2016129, 2018794, 2027463, 2029395, or 2033280. These anchors were sold in the U.S. starting from 2012.
Verify the product number and batch numbers listed in the recall notice to confirm if your item is affected.
The product is safe for use if the packaging seal is intact. However, if the pouch is improperly sealed, it could lead to contamination during surgery.
The recall does not specify a remedy, so you should check the product details to see if it is affected. If it is, contact Smith & Nephew for further instructions.
The recall does not provide specific visual indicators for a broken seal. You should check the product number and batch numbers to determine if it is affected.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0166-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0166-2021 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.
