A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.
- 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:
- Biomet, Inc.
- Reason for Recall:
- The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Product Codes/Lot Numbers:
Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.
Distribution:
Distributed in: TX, MD, PA, NJ, NC, MA, AZ, GA, FL, AR, CP
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2046-2015
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