medical MODERATE Updated 2018-03-21

Zimmer Biomet, Inc. recalls VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK

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Recalled Product

VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Item Number: 00-7843-013-56 Lot Numbers: 61993635 61987936 62011961 Item Number: 00-7843-013-06 Lot Numbers: 61721714 62097225

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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