Facility
MEDTECH LLC
4 recall(s) on record — most severe on record: Class I.
| FDA Establishment Identifier (FEI) | 3010123256 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | 8022 Martha Rd Millington, TN, US 38053 |
| Registration status | Active · expires 2026 |
| Parent company | MedTech-LLC (owner-operator 10043432) |
| Brand names | Gorilla, Mini, Drill Guide, Compression Slot; Gorilla, R3con, Drill Guide Compression Slot; Gorilla, Silverback, Drill Guide Compression Slot |
Devices registered here (3)
- Plate, Fixation, BoneProduct code HRS · Class II · Orthopedic · 21 CFR 888.3030
- Washer, Bolt NutProduct code HTN · Class II · Orthopedic · 21 CFR 888.3030
- Screw, Fixation, BoneProduct code HWC · Class II · Orthopedic · 21 CFR 888.3040
Recalls & enforcement
- Class IOngoing2021-09-22The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or
- Class IITerminated2020-01-06Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
- Class ITerminated2019-09-10The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
- Class IITerminated2018-05-08Replacement of units lacking an updated device approval.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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