Recall Z-0941-2018— Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2017-07-21, terminated 2020-03-12. It names 2 FDA 510(k) clearances: K143085, K121308. Product: Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535. Reason: Inner and outer sterile barriers not fully sealed..
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-21
- Terminated
- 2020-03-12
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K143085 — Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
- K121308 — HIP SYSTEMS
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
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Reason for recall
Inner and outer sterile barriers not fully sealed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.