Recalls / —
—#160966
Product
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
- FDA product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K011857
- Affected lot / code info
- Lot H302839, Expiration Date 31Jan2026
Why it was recalled
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Root cause (FDA determination)
Employee error
Action the firm took
The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned.
Recalling firm
- Firm
- Synthes (USA) Products LLC
- Address
- 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986
Distribution
- Distribution pattern
- TX, GA, PA, UT and Canada
Timeline
- Recall initiated
- 2017-07-21
- Terminated
- 2018-07-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160966. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.