[pending] BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Pending LLM rewrite. Source: FDA_DEVICE Z-0957-2026.
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
Removal of affected lot of screws due to labeling error.
The recalled product
- Product
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Manufacturer
- Smith & Nephew, Inc.
- 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 (6)
- Model No. 72201768
- 72204389
- UDI: 03596010611642
- 00885554036572
- Batch No. 51315219
- 51306803.
Distribution
Distributed nationwide across the United States.
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