Z-1060-2012

Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm...

Name: Z-1060-2012 Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm...
Creator: Ascension Orthopedics, Inc
Published: 2011-12-03
License: https://open.fda.gov/license/

Ascension Orthopedics, Inc. / initiated 2011-12-03 / Terminated / root cause: design

FDA source

Ascension Orthopedics, Inc began a recall of 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... on 2011-12-03. The reason FDA records is "A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1060-2012
Status: Terminated
Initiated: 2011-12-03
Posted: 2012-02-17
Terminated: 2013-01-14
Recalling firm: Ascension Orthopedics, Inc.
Product: 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
Product code: KXE Prosthesis, Wrist, Hemi-, Ulnar
Reason for recall: A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA.
Root cause tag: design
FDA root cause: Device Design
Action: The Firm, Ascension Orthopedics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 3, 2011 via FedEx, email or fax to all customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately cease any further use of any affected product; remove from their stockrooms until it is shipped back to Ascension Orthopedics; promptly return any affected product to: Ascension Orthopedics, 8700 Cameron Road, Austin, TX 78754, Attn: First Choice DRUJ Recall Administrator, and complete and return the reply form even if you do not have affected product in stock, to Regulatory Affairs Dept. via fax to 512-836-6933. If you have any questions, please do not hesitate to contact customer service at 1-512-836-5001.
Quantity in commerce: 1303 units released to customers
Distribution: Worldwide distribution.
Product codes and lots: 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.

Product code KXE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)