Reported Feb 8, 2017 · Terminated

Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary…

Synthes (USA) Products LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986

Synthes Radial Head Prosthesis System, Surgical instrument
motors and accessories Product UsageIntended for primary and revision joint replacement of the radial head

Lot codes and dates: Part Numbers
99 of 99 codes
03.402.006
03.402.007
03.402.008
03.402.009
03.402.010
03.402.018
03.402.020
03.402.022
03.402.024
03.402.026
03.402.028
03.402.106
03.402.107
03.402.108
03.402.109
03.402.110
03.402.218
03.402.220
03.402.222
03.402.224
03.402.226
03.402.228
03.402.418
03.402.420
03.402.422
03.402.424
03.402.426
03.402.428
03.402.618
03.402.620
03.402.622
03.402.624
03.402.626
03.402.628
03.402.701
03.402.710
03.402.711
03.402.712
03.402.716
03.402.717
03.402.718
03.402.719
03.402.720
03.402.721
03.402.722
03.402.723
03.402.724
03.402.725
03.402.726
03.402.727
03.402.728
03.402.729
03.402.730
03.402.731
03.402.732
03.402.733
03.402.734
03.402.735
03.402.740
03.402.741
Amount recalled: 50,311 units

There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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58 in total.