Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
This recall has been terminated (originally issued May 7, 2020).
- Company
- Howmedica Osteonics Corp.
- Recall Initiated
- April 16, 2020
- Posted
- May 7, 2020
- Terminated
- November 15, 2021
- Recall Number
- Z-2098-2020
- Quantity
- 4895
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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
Lot / Code Info
Lot #s YX05L9, AL6MM6, VX02E2, 5Y1H86, XY5HP7, MA49HV, A26E76, 4V4APT, LD87TH, MH1RLL, 8R05HH, A67K6H, Y00YXH, PA02HR, LE0L4W, 494M8R, 4T4RAV, PW2E41, 3T59A5, T384A0, PD2Y0T, V44JY5, 650WXN, 3D3H6W, DT2YN6, M550AN, 3N0PN7, YA60V9, DV13RY, 4M1NHR, 3M48X6, LR49YE, NT897W, DX8JV1, VN44ME, VR1H7D, TW4EJ0, T722PN, 6V04AX, 390D9L, KW3W1W, 4D6DWK, W079A2, Y81W0J
Root Cause
Packaging
Action Taken
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.