Recall Z-0514-2020— Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2019-10-03, terminated 2022-04-21. It names one FDA 510(k) clearance: K121308. Product: Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025. Reason: Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015).
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-03
- Terminated
- 2022-04-21
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Reason for recall
Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
Data sourced from openFDA. This site is unofficial and independent of the FDA.