QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
- Recall Initiated
- June 22, 2018
- Terminated
- July 8, 2019
- Recall Number
- Z-2904-2018
- 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
1000107793, 1000107794, 1000107795, 1000111407, 1000113293, 1000119681, 1000119682, 1000124116, 1000130031, 1000134145, 1000139203, 1000141585, 1000148808, 1000150571, 1000156031, 1000159892, 1000166365, 1000168534, 1000169198, 1000170705, 1000171359, 1000174838, 1000176391, 1000183609, 1000188544, 1000189237, 1000191063, 1000193586, 1000195789, 1000202429, 1000215159, 1000217674, 1000220165, 1000224225, 1000231906, 1000233773, 1000236827, 1000239654, 1000245176, 1000251377, 1000254803, 1000262514
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.