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.
FDA Recall Z-1550-2010 · Posted 2010-05-07
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Recalling FirmStryker Craniomaxillofacial Division
Recall StatusTerminated
Product CodeHWC
Date Initiated2010-03-05
Date Terminated2012-06-06
Product Quantity184 packs (5/pack)
Reason for Recall
During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.
Firm Action
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]
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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