Recall Z-1267-2013
Symmetry Medical/SSI · initiated April 10, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160
Reason for recall
There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.
FDA-determined cause: Under Investigation by firm
Action taken
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 Recall Response Form and fax the completed form to 615-964-5567. Customers with questions were instructed to call 615-964-5515. For questions regarding this recall call 615-964-5515.
Details
- Recall number
- Z-1267-2013
- Initiated
- April 10, 2013
- Posted by FDA
- May 7, 2013
- Terminated
- May 12, 2014
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- 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
- Recalling firm
- Symmetry Medical/SSI, Antioch, TN