Recall Z-2912-2018
Stryker Leibinger GmbH & Co. KG · initiated June 22, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Codes / lots: 1000201620, 1000203741, 1000215161, 1000221838, 1000224226, 1000230171, 1000232403, 1000233774, 1000235432, 1000236133, 1000238416, 1000245179, 1000251379, 1000254404, 1000255711, 1000257449, 1000258651, 1000258652, 1000259409, 1000260283, 1000260284, 1000260285, 1000261025, 1000261026, 1000261689, 1000261690, 1000261691, 1000263498, 1000263499, 1000263500, 1000263501, 1000263502, 1000264407, 1000264408, 1000265423, 1000265424, 1000266165, 1000266166, 1000266167, 1000267009, 1000267010, 1000267748, 1000267749, 1000267750, 1000268573, 1000268574, 1000269518, 1000269519, 1000270162, 1000270163, 1000270837, 1000270838, 1000285715, 1000287395, 1000289257, 1000201620, 1000288210, 1000290246, 1000291275, 1000292116, 1000294081
Reason for recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
FDA-determined 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.
Details
- Recall number
- Z-2912-2018
- Initiated
- June 22, 2018
- Terminated
- July 8, 2019
- Product code
- GWO – Plate, Cranioplasty, Preformed, Alterable
- Quantity
- 22,831 total
- Distribution
- US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
- Recalling firm
- Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2898-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2899-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2900-2018 Class II | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2901-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2902-2018 Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2903-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2904-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2905-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2906-2018 Class II | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2907-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2908-2018 Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2909-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2910-2018 Class II | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2911-2018 Class II | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2913-2018 Class II | AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2914-2018 Class II | AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2915-2018 Class II | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |