CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
130 Degree Titanium Trochanteric Fixation Nail/Right, Sterile recalled
Synthes (USA) Products is recalling 130 Degree Titanium Trochanteric Fixation Nail/Right, Sterile, distributed in Georgia, Pennsylvania, Texas, Utah. The recall was initiated on 21 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0604-2018
- FDA event ID
- 78958
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jul 2017
- FDA classified
- 13 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Jul 2017 | Recall initiated by company | |
| 13 Feb 2018 | Classified by FDA | +207 days |
| 21 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Where it was distributed
TX, GA, PA, UT and Canada
Questions about this recall
Why was it recalled?
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Which lots are affected?
Lot H302839, Expiration Date 31Jan2026
Where was it sold?
TX, GA, PA, UT and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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