MANOS EX — Class II medical device recall Z-0702-2017
Terminated recall by Thayer Intellectual Property, Inc., reported 2016-12-14, distributed nationwide. The firm failed to notify current customers of IFU update/warning. During a recent FDA inspection, it was disc
| Recall number | Z-0702-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thayer Intellectual Property, Inc., Walnut Creek, CA, United States |
| Recall initiated | 2016-11-04 |
| Classified | 2016-12-03 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 339 devices |
| Reason classes | device malfunction |
| Lot numbers | 1055337, 1071800, 1102580, 1154179 |
| Model numbers | TY-12-101 |
| Expiration dates | 2015-04-01, 2017-05-01, 2017-08-01, 2017-12-01 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0702-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.