10 mm/135 degree Titanium Cannulated Trochanteric Fixation… recallZ-0219-2015 · Synthes, Inc. · initiated Oct 29, 2014
Class II Terminated All recalls posted in November 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-0219-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 29, 2014
- Posted by the FDA
- Nov 14, 2014
- Recalling firm
- Synthes, Inc.
- Quantity
- 6
- Product code
- HSB
- FDA submissions
- K011857
- Distribution
- US Distribution in the states of: AK, FL, OH, OK, and TX.
Product description
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Code information (models, lots, serial numbers)
part number: 456.316S, lot number: 7782247
Other devices under the same FDA submission
44 devices cleared under K011857 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 456.305Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- NA 456.303Synthes GmbH · Screw, fixation, bone7 reports
- NA 456.315SSynthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- NA 456.318SSynthes GmbH · Screw, fixation, bone6 reports
- NA 456.306Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- NA 456.302Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- NA 456.304SSynthes GmbH · Screw, fixation, bone4 reports
- NA 456.306SSynthes GmbH · Screw, fixation, bone4 reports
- NA 456.322SSynthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- NA 456.420SSynthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- NA 456.305SSynthes GmbH · Screw, fixation, bone3 reports
- NA 456.415SSynthes GmbH · Screw, fixation, bone3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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