—#161221

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

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: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304

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 #161221. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.