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 Craniomaxillofac
FDA device recall Z-1550-2010 · posted 2010-05-07 · Terminated
Recall details
- Recalling firm
- Stryker Craniomaxillofacial Division
- Reason for recall
- During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 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.
- Date initiated
- 2010-03-05
- Date posted
- 2010-05-07
- Date terminated
- 2012-06-06
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INION CPS BSSO SCREW (K020266) | Inion , Ltd. | 2002-02-22 |
| CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM (K010352) | Inion , Ltd. | 2001-03-14 |