FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
- Recall number
- Z-0452-2014
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
- Status
- Terminated
- Initiated
- 2013-07-30
- Posted
- 2013-12-05
- Terminated
- 2015-09-10
- Reason
- Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 17
- Distribution
- Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
- Lot, serial or model codes
- Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.
- 510(k) numbers
- ["K011857"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28