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U.S. Department of Health and Human Services

Class 2 Device Recall First Choice Partial Ulnar Head System ("DRUJ System").

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 Class 2 Device Recall First Choice Partial Ulnar Head System ("DRUJ System").see related information
Date Initiated by FirmDecember 03, 2011
Date PostedFebruary 17, 2012
Recall Status1 Terminated 3 on January 14, 2013
Recall NumberZ-1060-2012
Recall Event ID 60855
Product Classification Prosthesis, wrist, hemi-, ulnar - Product Code KXE
ProductAscension 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
Code Information 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.
FEI Number 3002788818
Recalling Firm/
Manufacturer		 Ascension Orthopedics, Inc
8700 Cameron Rd Ste 100
Austin TX 78754-3947
For Additional Information ContactStan Harris
512-836-5001
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionThe 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 Commerce1303 units released to customers
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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