10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
FDA Recall Z-0219-2015 · Posted 2014-11-14
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Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2014-10-29
Date Terminated2015-12-18
Product Quantity6
Reason for Recall
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
US Distribution in the states of: AK, FL, OH, OK, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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