Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-808

FDA device recall Z-1267-2013 · posted 2013-05-07 · Terminated

Recall details

Recalling firm

Symmetry Medical/SSI

Reason for recall

There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DWS

Quantity affected

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

Date initiated

2013-04-10

Date posted

2013-05-07

Date terminated

2014-05-12

Location

Antioch, TN