[pending] Genesis Knotless Anchor
Pending LLM rewrite. Source: FDA_DEVICE Z-1170-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
The recalled product
- Product
- Genesis Knotless Anchor
- Manufacturer
- Aju Pharm Co., Ltd.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model No. 10KPN4751
- 10KPN5501
- All UDI Codes
- All Lots.
Distribution
Distributed nationwide across the United States.
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