Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
FDA Recall Z-1124-2017 · Posted None
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeKWI
Date Initiated2016-12-29
Date Terminated2018-02-06
Product Quantity50,311 units
Reason for Recall
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
Firm 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.
Root Cause
Under Investigation by firm
Distribution Pattern
United States Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.