Reported Dec 14, 2016 · Terminated
MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal…
Thayer Intellectual Property, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thayer Intellectual Property, Inc. · 1331 N California Blvd Ste 320 · Walnut Creek, CA · 94596-4563
Is this the product you have?
- MANOS EX (CAT#TY-12-101)
- Product UsageCarpal
- Tunnel Releaseas a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy
- Plantar Fasciotomyas a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy
- Lot codes and dates
LOT 1055337Expiry 4/01/2015LOT 1071800. Expiry 5/1/2017LOT 1102580Expiry 8/1/2017LOT 1154179Expiry 12/01/2017
- Amount recalled
- 339 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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