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Terminated

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

FDA Recall Z-0604-2018 · Posted None

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHSB
Date Initiated2017-07-21
Date Terminated2018-07-10
Product Quantity4 units

Reason for Recall

The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

Firm Action

The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned.

Root Cause

Employee error

Distribution Pattern

TX, GA, PA, UT and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011857SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEMSynthes (Usa) · 2001-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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