Aju Pharm recalls Fixone Biocomposite Anchors (models BAB-55003ch, BAN-55003b, SAB-30002e) due to reported anchor breakage and suture failure. All units with UDI codes are affected.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm is recalling Fixone Biocomposite Anchors that have been reported to break, bend, or pull out, potentially causing suture failure. This could lead to injury if the anchor fails during use.
The anchors can break, bend, or pull out during use, which may cause sutures to fail. This could lead to injury or complications during medical procedures if the anchor does not hold properly.
Users of Fixone Biocomposite Anchors for medical procedures are affected. Patients and medical staff using these anchors during surgery or procedures are at risk of injury if the anchor fails.
Check for model numbers BAB-55003ch, BAN-55003b, or SAB-30002e on the anchor. All units with a UDI code are included in this recall.
Look for model numbers BAB-55003ch, BAN-55003b, or SAB-30002e on the anchor.
Contact Aju Pharm directly for further assistance with the recall.
Yes, all units with model numbers BAB-55003ch, BAN-55003b, or SAB-30002e and UDI codes are affected.
Check for the model numbers and contact Aju Pharm for further assistance.
Reports indicate anchor breakage and suture failure, which could lead to injury during medical procedures.
We’ve drafted a message you can send Aju Pharm to request your refund or repair — edit it as you like.
Subject: Recall Z-1167-2026 — Aju Pharm Aju Pharm Hello, I own a Aju Pharm that is covered by recall Z-1167-2026 from Aju Pharm. 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.
