Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby… recallZ-1550-2010 · Stryker Craniomaxillofacial Division · initiated Mar 5, 2010
Terminated All recalls posted in May 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
During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm, Stryker, issued two "URGENT PRODUCT RECALL NOTIFICATION" letters, dated March 5, 2010 and March 19, 2010, to customers. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory for the catalogue and lot numbers, return the enclosed confirmation indicating the location of the affected product, return any remaining product to Stryker at the noted address, and provide a copy of this notification to any site that they may have distributed the product to. If you have any further questions, contact Rob Yamashita, Sr. Regulatory Affairs Rep at (269) 323-4258 or email: [email protected]
Recall details
- Recall number
- Z-1550-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 5, 2010
- Posted by the FDA
- May 7, 2010
- Recalling firm
- Stryker Craniomaxillofacial Division
- Quantity
- 184 packs (5/pack)
- Product code
- HWC
- FDA submissions
- K010352, K020266
- Distribution
- Nationwide distribution: CA, CO, CT, FL, GA, IL, LA, MA, MD, ME, MO, MT, NC, NH, NJ, NM, NY, OH, PA, RI, SC, TX and WI.
Product description
Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI. The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a craniomaxillofacial plating system intended to maintain accurate alignment of bone fractures and osteotomies in the cranium and mid-face.
Code information (models, lots, serial numbers)
Lot numbers 0808009 and 0809069. Model number SCR1221.
Other devices under the same FDA submission
4 devices cleared under 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
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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