Recalls / —
—#125053
Product
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog no. 2124-1400 All lots
Why it was recalled
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Root cause (FDA determination)
Process design
Action the firm took
Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- IL MA, MN, ND, OR, & PA
Timeline
- Recall initiated
- 2013-11-20
- Posted by FDA
- 2014-02-10
- Terminated
- 2016-10-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125053. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.