stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial numbers: D32158, D32160, D32161, D32162, D32163, D32164, D34343, D34344, D40690, D41629, D41630, D41631, D44713, G16331, G16332, G16333, G26278, G29759, G29760, G32730, G32731, G32735, G45119, H30398, H30399, H66392
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker GmbH
- Reason for Recall:
- Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
Product Codes/Lot Numbers:
Serial numbers: D32158, D32160, D32161, D32162, D32163, D32164, D34343, D34344, D40690, D41629, D41630, D41631, D44713, G16331, G16332, G16333, G26278, G29759, G29760, G32730, G32731, G32735, G45119, H30398, H30399, H66392
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1191-2023
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