Manos EX recall
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…
Why was Manos EX recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOT 1055337, Expiry 4/01/2015; LOT 1071800. Expiry 5/1/2017; LOT 1102580; Expiry 8/1/2017; LOT 1154179; Expiry 12/01/2017.
- 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…
- Recalling firm
- Thayer Intellectual Property, Inc.
- Quantity
- 339 devices
- Distribution
- US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID, SD, IN, and GA.
- Recall date
- December 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)