Recall Z-0702-2017 ยท LXH Orthopedic Manual Surgical Instrument
Thayer Intellectual Property, Inc.
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.
| Date | Nov 4, 2016 |
| Status | Terminated |
| Reason | 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 fi |
| 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 | 339 devices |
| Distribution | US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID, SD, IN, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.