Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1039-2018)

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:

LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT 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-1039-2018

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:

Code Information:

00-5990-014-31 61938548 00-5990-014-32 00-5990-015-31 00-5992-014-31 00-5992-015-31

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