Restoration Anatomic Shell (2020-04-16)
- Starting date:
- April 16, 2020
- Posting date:
- May 1, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72949
Last updated: 2020-05-01
Affected Products
Restoration Anatomic Shell
Reason
Through Stryker's complaint handling program, Stryker has discovered that the Restoration Anatomic Shell (RAS) implants, sizes 54mm - 68mm (left and right), may fall off its post within its inner packaging. The loose implant within the packaging can result in packaging debris and/or debris from the device coating.
Affected products
Restoration Anatomic Shell
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 504-02-54C-L
- 504-02-54C-R
- 504-02-56D-L
- 504-02-56D-R
- 504-02-58D-L
- 504-02-58D-R
- 504-02-60D-L
- 504-02-60D-R
- 504-02-62E-L
- 504-02-62E-R
- 504-02-64E-L
- 504-02-64E-R
- 504-02-66F-L
- 504-02-66F-R
- 504-02-68F-L
- 504-02-68F-R
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
07430
New Jersey
UNITED STATES