Howmedica Osteonics Corp.: Medical Device Recall in 2024 - (Recall #: Z-0910-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631

Product Classification:

Class II

Date Initiated: December 1, 2023

Date Posted: February 7, 2024

Recall Number: Z-0910-2024

Event ID: 93687

Reason for Recall:

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Status: Ongoing

Product Quantity:

Code Information:

GTIN: 04546540306203 Lot Numbers: 36272501,42380501 42771601

Distribution Pattern:

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated