Class 2 Device Recall Inion Baby Screw

• Date Initiated by Firm: March 05, 2010
• Date Posted: May 07, 2010
• Recall Status: Terminated on June 06, 2012
• Recall Number: Z-1550-2010
• Recall Event ID: 55179
• 510(K)Number: K010352 K020266
• Product Classification: screw, fixation, plate, bone - Product Code HWC
• Product: 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: Lot numbers 0808009 and 0809069. Model number SCR1221.
• Recalling Firm/ Manufacturer: Stryker Craniomaxillofacial Division; 750 Trade Centre Way; Ste 200; Portage MI 49002-0482
• For Additional Information Contact: Rob Yamashita; 877-534-2464
• Manufacturer Reason for Recall: During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.
• FDA Determined Cause: Nonconforming Material/Component
• 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: rob.yamashita@stryker.com
• Quantity in Commerce: 184 packs (5/pack)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HWC