Recall Z-0918-2024— Howmedica Osteonics Corp.
Class II · Ongoing
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2023-12-01. It names 3 FDA 510(k) clearances: K032163, K032418, K915512. Product: DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200. 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
3 on FDA's record- K032163 — DURACON TOTAL KNEE SYSTEM
- K032418 — DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
- K915512 — DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
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
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
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.