AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
- Recall Initiated
- June 22, 2018
- Terminated
- July 8, 2019
- Recall Number
- Z-2913-2018
- Quantity
- 22,831 total
Reason for Recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Distribution
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Lot / Code Info
1000201635, 1000215162, 1000230807, 1000236134, 1000253512, 1000256558, 1000258653, 1000260286, 1000263503, 1000261692, 1000265425, 1000265426
Root Cause
Package design/selection
Action Taken
URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken: 1. Please inform users of this Medical Device Removal and pass this notice to all appropriate individuals within your organization. 2. Return all affected products available at your location to: Stryker CMF Attn: Recall Coordinator 6300 Sprinkle Rd Portage, MI 49002 REF: PFA #1739180 Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: (877) 648-7114 or email a copy to CMF-custserv@stryker.com. 4. Keep a copy of the completed and executed Customer response Form for your records.