IMPLANTECH ASSOCIATES, INC.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Retention Device, SutureProduct code KGS (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4930
Recalls & enforcement
- Class IITerminated2014-01-29Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.
- Class IITerminated2013-08-30Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “IMPLANTECH ASSOCIATES, INC. (FEI 1000142697) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000142697-implantech-associates-inc/
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