Thayer MANOS EX Surgical Device Recalled for Missing Safety Warning
Thayer Intellectual Property, Inc. is recalling 339 MANOS EX surgical devices because customers were not notified of a critical safety warning regarding device bending and breakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Severe because the source text reports a specific injury (tendon injury) and the need for additional surgery resulting from device breakage, which aligns with the rubric criterion for significant injury reports.
Plain-English summary
Thayer Intellectual Property, Inc. is recalling 339 units of the MANOS EX surgical device (Catalog #TY-12-101). The device is used for carpal tunnel release and plantar fasciotomy procedures. The recall is being conducted because the manufacturer failed to notify current customers of an updated Instructions for Use (IFU) that includes a warning against bending, deforming, or modifying the device.
During a recent FDA inspection, it was discovered that the firm had revised the IFU to include this warning following a Medical Device Reporting (MAUDE) report from December 2014. In that incident, a piece of the device broke during use and was left in a patient's hand, resulting in a tendon injury and the need for additional surgery to remove the broken piece and repair the tendon. The FDA found that while the firm had updated the documentation, they had not informed customers who had already received the device with the older version of the IFU.
The affected devices were distributed nationwide in California, Texas, Maryland, Michigan, Virginia, the District of Columbia, Utah, Connecticut, Idaho, South Dakota, Indiana, and Georgia. The specific lot numbers and expiration dates are: LOT 1055337 (Expiry 4/01/2015), LOT 1071800 (Expiry 5/1/2017), LOT 1102580 (Expiry 8/1/2017), and LOT 1154179 (Expiry 12/01/2017). Users should be aware that bending, deforming, or modifying the device could result in breakage, which impacts patient safety and device performance.
The recalled product
- 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 fas
- Manufacturer
- Thayer Intellectual Property, Inc.
- Affected units
- 339
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- LOT 1055337
- Expiry 4/01/2015
- LOT 1071800. Expiry 5/1/2017
- LOT 1102580
- Expiry 8/1/2017
- LOT 1154179
- Expiry 12/01/2017.
Distribution
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