RegWardenFDA facility compliance records
Company

IMPLANTECH ASSOCIATES, INC.

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls1’131’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2014-01-29
    Implantech 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 IITerminated2013-08-30
    Implantech 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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “IMPLANTECH ASSOCIATES, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9000198-implantech-associates-inc/

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