Recall Z-0702-2017— Thayer Intellectual Property, Inc.

Class II FDA medical device recall by Thayer Intellectual Property, Inc., initiated 2016-11-04, terminated 2017-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.. Reason: The firm failed to notify current customers of IFU update/warning. During a recent FDA inspection, it was discovered that Thayer Intellectual Property, Inc. had revised their IFU to include a warning not to bend, deform or otherwise modify any part of the device. The warning was added as a result of a MAUDE report filed in December 2014 where a piece of the MANOS EX broke during use and was left in the patient's hand. The patient suffered a tendon injury and an additional surgery was required to remove the broken piece of the device and repair the tendon. FDA inspection found that while the firm had updated their IFU, they had not notified customers who had been shipped the device with the older version that did not include the warning. Risk: It is important for MANOS EX users to be aware that bending, deforming, or modifying the device could result in device breakage which could impact patient safety and device performance..

Recalling firm

Thayer Intellectual Property, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-11-04

Terminated

2017-12-13

Firm location

Walnut Creek, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.