RegWardenFDA facility compliance records
Facility

TEDAN SURGICAL INNOVATIONS, INC.

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2017: 1 inspections; 2019: 2 recalls; 2020: 1 recalls1’12’13’14’15’161’17’182’191’20’21’22’23’24’25’26
  • Recalls (4)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2020-05-15
    Lack of pouch seal. Product is labelled as sterile.
  • Class IITerminated2019-07-16
    There was incorrect raw material used in the production of the identified lot.
  • Class IITerminated2019-02-18
    The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
  • Class IITerminated2012-06-11
    This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out…

FDA inspections (1)

  • NAI2017-06-02
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “TEDAN SURGICAL INNOVATIONS, INC. (FEI 3005726885) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005726885-tedan-surgical-innovations-inc/

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