FDA Recall
Terminated
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Recall: Z-1124-2017
·
Initiated December 29, 2016
Recall
- Recall Number
- Z-1124-2017
- Event Number
- 76182
- Firm
- Synthes (USA) Products LLC
- FEI Number
- 3008812560
- Product Code
- KWI
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 29, 2016
- Terminated
- February 6, 2018
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986
Description
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Reason
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
Action
An Urgent Notice was mailed to consignees explaining the reason for the recall. Customers were asked to immediately review their inventories for the affected product and complete and return the Verification form that was included with the notification and return any of the affected product that was found.
Distribution
United States Nationwide Distribution.
Quantity
50,311 units