Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AZ, AR, CA, CO, CT, DE, FL, IL, IA, KS, LA, MD, MA, MI, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, RI, TN, TX, UT, VA