Z-0702-2017Class II

Manos Ex (Cat#ty-12-101)

Name: Z-0702-2017 Manos Ex (Cat#ty-12-101)
Creator: Thayer Intellectual Property, Inc.
Published: 2016-11-04
License: https://open.fda.gov/license/

Thayer Intellectual Property, Inc. / initiated 2016-11-04 / Terminated / root cause: packaging

FDA source

Thayer Intellectual Property, Inc. began a recall of 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... on 2016-11-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0702-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-04
Posted: 2016-12-03
Terminated: 2017-12-13
Recalling firm: Thayer Intellectual Property, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Thayer sent an Urgent Medical Device Correction letters dated November 4, 2016 by Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were asked to check if any of the affected lots were still available, and if so, to change out the IFU with version 5. For questions call 415-923-9375.
Quantity in commerce: 339 devices
Distribution: US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID, SD, IN, and GA.
Product codes and lots: LOT 1055337, Expiry 4/01/2015; LOT 1071800. Expiry 5/1/2017; LOT 1102580; Expiry 8/1/2017; LOT 1154179; Expiry 12/01/2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0702-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0702-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-03

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)