Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and

FDA device recall Z-1060-2012 · posted 2012-02-17 · Terminated

Recall details

Recalling firm

Ascension Orthopedics, Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KXE

Quantity affected

1303 units released to customers

Distribution

Worldwide distribution.

Date initiated

2011-12-03

Date posted

2012-02-17

Date terminated

2013-01-14

Location

Austin, TX