Recall Z-1060-2012 ยท KXE Prosthesis, Wrist, Hemi-, Ulnar
Ascension Orthopedics, Inc
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 arthr
| Date | Feb 17, 2012 (initiated Dec 3, 2011) |
| Status | Terminated |
| Reason | 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 | 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 affe |
| Quantity | 1303 units released to customers |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.