Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
Class I - DangerousWhat Should You Do?
- Check if you have this product: 61288759 61542760 61710043 61729725 61735130 61768446 61805951 61843648 61874222 61950885 61957017 61967640 61967642 61985977 62010557 62014550 62059104 62124960 62134980 62153554 62163677 62191383 62225911 62270944 62273474 62275220 62275874 62316364 62329143 62356225 62418056 62420829 62420831 62420832 62432973 62472159 62503173 62521423 62521424 62521425 62521426 62540539 62571382 62578409 62652963 62659314 62659315 62667476 62700958 62721036 62739979 62761717 62776407 62787314 62787315 62794382 62815408 62836783 62836785 62885067 62939020 62939021 62939023 63044942 63051893 63063344 63063345 63063346 63063348 63068961 63068965 63068967 63068969 63076579 63076580 63081284 63081286 63090043 63090044 63094542 63102029 63102030 63108843 63174078 63174079 63174081 77004214 61429027R 62066989R 62335432R 62836786R
- 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:
- M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
Product Codes/Lot Numbers:
61288759 61542760 61710043 61729725 61735130 61768446 61805951 61843648 61874222 61950885 61957017 61967640 61967642 61985977 62010557 62014550 62059104 62124960 62134980 62153554 62163677 62191383 62225911 62270944 62273474 62275220 62275874 62316364 62329143 62356225 62418056 62420829 62420831 62420832 62432973 62472159 62503173 62521423 62521424 62521425 62521426 62540539 62571382 62578409 62652963 62659314 62659315 62667476 62700958 62721036 62739979 62761717 62776407 62787314 62787315 62794382 62815408 62836783 62836785 62885067 62939020 62939021 62939023 63044942 63051893 63063344 63063345 63063346 63063348 63068961 63068965 63068967 63068969 63076579 63076580 63081284 63081286 63090043 63090044 63094542 63102029 63102030 63108843 63174078 63174079 63174081 77004214 61429027R 62066989R 62335432R 62836786R
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2369-2018
Related Recalls
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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.