Facility

Pioneer Surgical Technology, Inc.

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

Key facts

3recalls · worst Class II

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000115331
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	375 RIVER PARK CIRCLE Marquette, MI, US 49855
Registration status	Active · expires 2026
Parent company	Pioneer Surgical Technology, Inc. (owner-operator 10084252)
Brand names	OSSE-LIGN

Activity by year

Recalls (3)
Inspections (4)

Devices registered here (1)

Cerclage, Fixation
Product code JDQ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3010

Recalls & enforcement

Class IITerminated2014-06-11
Lack of Sterility Assurance
Class IITerminated2013-06-14
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Class IITerminated2012-09-10
Some set screw thread profiles were found not to be within specifications.

FDA inspections (4)

VAI2024-06-14
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2023-05-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-03-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-06-23
Voluntary Action Indicated · Compliance: Devices · citations posted

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.

All facilities operated by Pioneer Surgical Technology, Inc.

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. “Pioneer Surgical Technology, Inc. (FEI 1000115331) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000115331-pioneer-surgical-technology-inc/

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