Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1037-2018)

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:

LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device is indicated for patients with severe knee pain and disability

Product Classification:

Class II

Date Initiated: November 29, 2017

Date Posted: March 21, 2018

Recall Number: Z-1037-2018

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:

00-5994-013-91 61758275 00-5994-013-92 61758283 00-5994-014-92 61768114 00-5994-014-92 11004374 00-5994-014-92 11004966 00-5994-014-92 11006826 00-5994-015-91 11003022 00-5994-015-92 61771825 00-5994-015-92 61771822 00-5994-015-92 61771828 00-5994-015-92 61771826 00-5994-015-92 61771827 00-5994-016-91 61768099 00-5994-016-91 61771829 00-5994-016-91 11005670 00-5994-016-92 61768104 00-5994-016-92 61771832

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