—#181282

Product

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K151264
Affected lot / code info: Lot #s Y461NK, 916M1K, 3581JK, 306XWX, AH4AER, YP48JA, 6J7PTL, KT81WD, 1D6NNE, 467JP5, 6M025E, T4286L, 633D81, 6L6ADX, N175H8, WJ41VD, RM697T, A602M0, 840Y1A, 988KM2, LL2VPW, Y37LK3, M35P5P, 280YM6, R62EM9, WM4W56, JE46JM, AK0560, D11734, EK644L, D802YL, HP25TN, L618D8, N532D2, NW0M02, 972H4A, 95171N, JD4934, WN7K01, V8245A, AK00NH, VL1688, 2E7J6X, 5030EN, P13E4K, K94NEN, MA5W63, 8X783D, 5A3RW3, TV13J7

Why it was recalled

The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.

Root cause (FDA determination)

Packaging

Action the firm took

Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North Carolina, Alabama, New Hampshire, Illinois, New Jersey, Virginia, Utah, Maryland, Mississippi, Missouri, Tennessee, Connecticut, and Kansas

Timeline

Recall initiated: 2020-04-16
Posted by FDA: 2020-05-07
Terminated: 2021-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181282. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.