Recall Z-0604-2018— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2017-07-21, terminated 2018-07-10. It names one FDA 510(k) clearance: K011857. Product: 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile. Reason: The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-21
- Terminated
- 2018-07-10
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Reason for recall
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Data sourced from openFDA. This site is unofficial and independent of the FDA.