Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
Class I - DangerousWhat Should You Do?
- Check if you have this product: 61349197 61690629 61721526 61781828 62010553 62118873 62130040 62201735 62258067 62275219 62356222 62361475 62484285 62496087 62546976 62559966 62578405 62616562 62634733 62652960 62700955 62733912 62798024 62808130 62808133 62869767 62869769 62953079 62993667 62993703 63034232 63038804 63044938 63068954 63068955 63068957 63076577 63081279 63094534 63094538 63102051 63128592 63128593 62521418R 62939011R 63128592R 77002646R
- 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 13.5; 00-7713-013-00
Product Codes/Lot Numbers:
61349197 61690629 61721526 61781828 62010553 62118873 62130040 62201735 62258067 62275219 62356222 62361475 62484285 62496087 62546976 62559966 62578405 62616562 62634733 62652960 62700955 62733912 62798024 62808130 62808133 62869767 62869769 62953079 62993667 62993703 63034232 63038804 63044938 63068954 63068955 63068957 63076577 63081279 63094534 63094538 63102051 63128592 63128593 62521418R 62939011R 63128592R 77002646R
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2368-2018
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