Recall Z-0875-2024— Howmedica Osteonics Corp.

Name: FDA recall Z-0875-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-01

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2023-12-01. It names one FDA 510(k) clearance: K994128. Product: SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321. Reason: 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..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-01
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K994128 — SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEMHowmedica Osteonics Corp.·cleared 2000-03-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.