Recalls / —
—#122361
Product
Titanium Trochanteric Fixation Nail (TFN)System 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 # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.
Why it was recalled
Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affeccted product to obtain a Return Authorization Number, Complete the Verification Section of the letter by checking the appropriate box indicating the affected product has been located. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132. Customers should complete and return the Verification Frorm even if they do not have any of the affected product and return by fax to 1-888-386-2077 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Trauma Sales Consultant. 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 IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
Timeline
- Recall initiated
- 2013-07-30
- Posted by FDA
- 2013-12-05
- Terminated
- 2015-09-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #122361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.