Device Recall First Choice Partial Ulnar Head System ("DRUJ System").

This recall applies to all of the First Choice DRUJ Partial Ulnar Head Devices. All lot numbers of the following Catalog Numbers are included:  DRUJ-610-1445-WW, DRUJ-610-1455-WW, DRUJ-610-1465-WW,  DRUJ-610-1645-WW,  DRUJ-610-1655-WW,  DRUJ-610-1665-WW,  DRUJ-610-1745-WW,  DRUJ-610-1755-WW,  DRUJ-610-1765-WW,  DRUJ-610-1945-WW,  DRUJ-610-1955-WW, and  DRUJ-610-1965-WW.

Orthopedic Devices

2

Yes

Worldwide distribution.

Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. || The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis