Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1041-2018)

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:

CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS FEM COMP SIZE H/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-1041-2018

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:

00-5972-015-01 61777593 00-5972-018-02 4002192 00-5970-012-02 61878272 00-5970-013-02 61777576 00-5970-013-02 62135909 00-5970-014-02 11400192 00-5970-014-02 62122787 00-5970-014-02 62135920 00-5970-014-02 62132399 00-5970-014-02 62132399R 00-5970-014-02 62135921 00-5970-015-02 11002229 00-5970-015-02 61777581 00-5970-015-02 62135936 00-5970-016-02 61777583 00-5970-016-02 62128113 00-5970-017-01 11003049 00-5970-018-01 61758971 00-5970-018-01 11003323 00-5970-018-02 11003330 00-5970-018-02 11003322

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