Recall Z-1550-2010 ยท HWC Screw, Fixation, Bone
Stryker Craniomaxillofacial Division
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.
| Date | May 7, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications. |
| Root 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 Ya |
| Quantity | 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. |
| FDA record | Open on fda.gov |