FDA Medical Device Recalls (openFDA)
Stryker Leibinger GmbH & Co. KG: AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
- Recall number
- Z-2910-2018
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Product
- AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
- Status
- Terminated
- Initiated
- 2018-06-22
- Posted
- not on file
- Terminated
- 2019-07-08
- Reason
- After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Root cause
- Package design/selection
- Action
- 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.
- Quantity
- 22,831 total
- Distribution
- US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
- Lot, serial or model codes
- 1000201514, 1000203740, 1000216825, 1000220166, 1000233195, 1000237514, 1000238415, 1000245178, 1000252563, 1000254189, 1000254403, 1000255709, 1000256557, 1000257448, 1000258647, 1000258648, 1000258649, 1000259406, 1000259407, 1000260281, 1000260282, 1000261023, 1000261024, 1000261687, 1000261688, 1000262515, 1000262516, 1000262517, 1000263497, 1000264403, 1000264404, 1000264405, 1000265422, 1000268571, 1000268572, 1000201514, 1000287394, 1000292115, 1000293285,
- 510(k) numbers
- ["K120352"]
- PMA numbers
- not on file
- Product code
- GWO
- Firm FEI
- 3002821504
- Firm city
- Freiburg Im Breisgau
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28