—#122353

Product

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K011857
Affected lot / code info: Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Why it was recalled

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Root cause (FDA determination)

Employee error

Action the firm took

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 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 take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were instructed to take the following steps: Complete the attached Verification Section at the end of the letter by checking the appropriate box indicating no affected product has been located. Return the documents to Synthes by fax to 610-251-9005 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-12-10
Terminated: 2015-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122353. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.