Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1026-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.
Product Description:

VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Classification:

Class II

Date Initiated: November 29, 2017
Date Posted: March 21, 2018
Recall Number: Z-1026-2018
Event ID: 78706
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.

Status: Terminated
Product Quantity: 13,227 in total
Code Information:

Item Number: 00-7843-012-36 Lot Number: 62132189 Item Number: 00-7843-013-36 Lot Numbers: 62085292 62120673 Item Number: 00-7843-015-36 Lot Numbers: 61695988 62089503 Item Number: 00-7843-017-36 Lot Number: 62097290

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated