FDA Recall
Terminated
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Recall: Z-0880-2016
·
Initiated January 21, 2016
Recall
- Recall Number
- Z-0880-2016
- Event Number
- 73156
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- MAY
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- January 21, 2016
- Posted
- February 25, 2016
- Terminated
- June 8, 2017
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006
Description
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Reason
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Action
Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.
Distribution
US Nationwide Distribution
Quantity
147,838 units in total