Recalls / —
—#161220
Product
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- FDA product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K121308, K143085
- Affected lot / code info
- Lot: 56211103, 56211401, 56211704, 57284004
Why it was recalled
Inner and outer sterile barriers not fully sealed.
Root cause (FDA determination)
Process control
Action the firm took
Recall notices were sent to customers with a request to return all affected product.
Recalling firm
- Firm
- Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2006
Distribution
- Distribution pattern
- Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
Timeline
- Recall initiated
- 2017-07-21
- Terminated
- 2020-03-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.