Z-1568-2013Class III

CMC Saddle

Name: Z-1568-2013 CMC Saddle
Creator: Integra LifeSciences Corp.
Published: 2013-06-03
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2013-06-03 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic... on 2013-06-03. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1568-2013
Classification: Class III
Status: Terminated
Initiated: 2013-06-03
Posted: 2013-06-21
Terminated: 2014-10-08
Recalling firm: Integra LifeSciences Corporation
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.
Product code: KYI Prosthesis, Wrist, Carpal Trapezium
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 467 devices
Distribution: USA Nationwide Distribution
Product codes and lots: Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1568-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1568-2013	Class III	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

Product code KYI

K061451Class IIAscension, Models Cmc-400,13,Cmc-400-20,Cmc-400-30,Cmc-400-40Ascension Orthopedics, Inc. / cleared 2006-08-11

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)