FDA Recall Terminated

02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

Recall: Z-1292-2011 · Initiated October 27, 2010

Recall

Recall Number: Z-1292-2011
Event Number: 57318
Firm: Synthes USA (HQ), Inc.
FEI Number: 3005180112
Product Code: KTW
Status: Terminated
Root Cause: Other
Initiated: October 27, 2010
Posted: February 16, 2011
Terminated: April 16, 2015
Address: 1302 Wrights Ln E, West Chester, PA, 19380-3417

Description

Reason

Potential for out of specification star grind teeth.

Action

Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time. Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the recalled product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. For questions regarding this recall call 1-800-620-7025, x 6883.

Distribution

Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.

Quantity