Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.
- 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 Howmedica Osteonics Corp.
- Reason for Recall:
- Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Product Codes/Lot Numbers:
Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0695-2013
Related Recalls
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Reunion TSA Peg Alignment Sound broke during surgery.
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
Stryker Howmedica Osteonics
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.