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U.S. Department of Health and Human Services

Class 2 Device Recall Inion Baby Screw

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 Class 2 Recall
Inion Baby Screw
see related information
Date Posted May 07, 2010
Recall Status1 Terminated on June 06, 2012
Recall Number Z-1550-2010
Recall Event ID 55179
Premarket Notification
510(K) Number
K020266 
Product Classification Screw, Fixation, 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, Michigan 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = INION LTD.
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