—#118634

Product

CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

FDA product code: KYI — Prosthesis, Wrist, Carpal Trapezium
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061451
Affected lot / code info: Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40.

Why it was recalled

As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Integra sent an Urgent: Medical Device Recall letter to all affected product. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, discontinue use, and complete and return the attached form. When the form is received, Customer Service Returns and Repairs will send an RMA number to return the affected inventory. For quwstions contact your regional managers or call 512-520-7697.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: USA Nationwide Distribution

Timeline

Recall initiated: 2013-06-03
Posted by FDA: 2013-06-21
Terminated: 2014-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.