—#96804

Product

02.122.555S, 55mm 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.

510(k) numbers: K080109
Affected lot / code info: All lots of Part Number: 02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile

Why it was recalled

Potential for out of specification star grind teeth.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

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

Timeline

Recall initiated: 2010-10-27
Posted by FDA: 2011-02-16
Terminated: 2015-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96804. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.