FDA Medical Device Recalls (openFDA)
Synthes, Inc.: 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
- Recall number
- Z-0219-2015
- Recalling firm
- Synthes, Inc.
- Product
- 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
- Status
- Terminated
- Initiated
- 2014-10-29
- Posted
- 2014-11-14
- Terminated
- 2015-12-18
- Reason
- The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
- Root cause
- Employee error
- Action
- An urgent medical device recall notice, dated October 29, 2014, was sent to end users that identified the product, problem and action to be taken. Customers were instructed to return the device to Synthes along with completing the verification section of the notice.
- Quantity
- 6
- Distribution
- US Distribution in the states of: AK, FL, OH, OK, and TX.
- Lot, serial or model codes
- part number: 456.316S, lot number: 7782247
- 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