FDAFDA · Food and drugs·Recall number Z-1023-2018
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Published March 21, 2018 · Recall initiated: November 29, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
- Lot
- Item Number: 00-7843-013-56 Lot Numbers: 61993635 61987936 62011961 Item Number: 00-7843-013-06 Lot Numbers: 61721714 62097225
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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