Aju Pharm recalls Genesis Screw-In Anchor models 10B450:10B65003 due to reported anchor breakage and suture failure. Affected units include all UDI codes and lots.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm is recalling Genesis Screw-In Anchor models 10B45003, 10B55003, and 10B65003 after reports of anchor breakage, bending, pull-out, and suture failure. This could lead to device malfunction during medical procedures.
The anchors can break, bend, or pull out during use, which may cause sutures to fail. This could lead to device malfunction during medical procedures if the anchor does not stay securely in place.
Patients using the Genesis Screw-In Anchor for medical procedures are most at risk. Healthcare providers who use these anchors in surgeries may also be affected.
Check for model numbers 10B45003, 10B55003, or 10B65003 on the product. All units with UDI codes and lots are affected.
Identify the model number on the device to confirm if it is affected.
Reach out to Aju Pharm for further assistance with the recall.
Models 10B45003, 10B55003, and 10B65003 are affected.
Check for model numbers 10B45003, 10B55003, or 10B65003 on the device. All units with UDI codes and lots are affected.
Contact Aju Pharm for further assistance with the recall.
We’ve drafted a message you can send Aju Pharm to request your refund or repair — edit it as you like.
Subject: Recall Z-1168-2026 — Aju Pharm Aju Pharm Hello, I own a Aju Pharm that is covered by recall Z-1168-2026 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.
