CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number: 00-8114-002-00 Lot Numbers: 62326105 61779347 62327662 62240744 62327663 62240745 62330760 62250379 62333960 62256011 62340054 62264280 62344682 62268572 62370963 62273048 62370965 62273049 62370966 62275085 62298278 62276441 62370975 62277490 62298279 62370968 62303495 62370969 62317907 62278684 62320168 62284463 62320169 62370971 62370976 62370972 62370978 62291922 62370979 62370973 62370990 62326104
- 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:
- Zimmer Biomet, Inc.
- Reason for Recall:
- The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Product Codes/Lot Numbers:
Item Number: 00-8114-002-00 Lot Numbers: 62326105 61779347 62327662 62240744 62327663 62240745 62330760 62250379 62333960 62256011 62340054 62264280 62344682 62268572 62370963 62273048 62370965 62273049 62370966 62275085 62298278 62276441 62370975 62277490 62298279 62370968 62303495 62370969 62317907 62278684 62320168 62284463 62320169 62370971 62370976 62370972 62370978 62291922 62370979 62370973 62370990 62326104
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1019-2018
Related Recalls
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Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.