1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001… recallZ-0631-2011 · Stryker Craniomaxillofacial Division · initiated Apr 14, 2010
Terminated All recalls posted in December 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Craniomaxillofacial Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
FDA root cause category: Other
What the company is doing
Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2010. The notice informed users of the change in the instructions for use (IFU), and included a copy of the revised IFU. The consignees were informed that the affected product does not need to be returned. Stryker can be contacted about this action at 877-534-2464 (option "Regulatory Affairs", reference Product Field Action #2009-445)
Recall details
- Recall number
- Z-0631-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 14, 2010
- Posted by the FDA
- Dec 16, 2010
- Recalling firm
- Stryker Craniomaxillofacial Division
- Quantity
- 8,631 all products
- Product code
- JEY
- FDA submissions
- K010351, K010352, K020266
- Distribution
- Nationwide Distribution: Throughout the US
Product description
1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile, Manufacturer, INION Oy, Finland.
Code information (models, lots, serial numbers)
Lot numbers of 0700000 and above.
Other devices under the same FDA submission
4 devices cleared under K010351, K010352, K020266 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 1.5 mm Inion CPS®Inion Oy · PLATE, BONE2 reports
- Inion CPS™ Baby 1Inion Oy · Screw, fixation, bone1 report
- 1.5 mm Inion CPS® BabyInion Oy · Screw, fixation, bone1 report
- Inion instrument 1Inion Oy · PLATE, BONE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 55861).
- Z-0630-2011 · Terminated1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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