Recall Z-1267-2013 ยท DWS Instruments, Surgical, Cardiovascular
Symmetry Medical/SSI
Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
| Date | May 7, 2013 (initiated Apr 10, 2013) |
| Status | Terminated |
| Reason | There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. |
| Root cause | Under Investigation by firm |
| Action | Symmetry Surgical sent an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to discontinue use of the product immediately and promplty call 800-251-3000 for a return material authorization (RMA) number and to identify if they would like credit or an alternative product. Customers were asked to fill out the attached |
| Quantity | 524 boxes of 10 |
| Distribution | Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.