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U.S. Department of Health and Human Services

Class 2 Device Recall MANOS EX

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  Class 2 Device Recall MANOS EX see related information
Date Initiated by Firm November 04, 2016
Create Date December 03, 2016
Recall Status1 Terminated 3 on December 13, 2017
Recall Number Z-0702-2017
Recall Event ID 75630
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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.
Code Information LOT 1055337, Expiry 4/01/2015; LOT 1071800. Expiry 5/1/2017; LOT 1102580; Expiry 8/1/2017; LOT 1154179; Expiry 12/01/2017.
Recalling Firm/
Thayer Intellectual Property, Inc.
1331 N California Blvd Ste 320
Walnut Creek CA 94596-4563
For Additional Information Contact Jeff Smith
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.