Facility

CENTINEL SPINE, LLC

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

Key facts

4recalls · worst Class II

—inspections in our data

—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)	3007494564
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	900 Airport Rd Ste 3B West Chester, PA, US 19380
Registration status	Active · expires 2026
Parent company	Centinel Spine, LLC (owner-operator 10026981)
Brand names	STALIF TT Flexible Awl Guide, Various sizes; STALIF Midline Flexible Awl Guide, Various Sizes; STALIF C Flexible Awl Guide, Various Sizes

Activity by year

Recalls (4)

Devices registered here (1)

Awl
Product code HWJ (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IIOngoing2026-03-20
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Class IIOngoing2025-12-31
Products were mislabeled as the 6mm product but included the 5 mm product.
Class IIOngoing2024-07-18
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Class IITerminated2021-03-05
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the pro…

All facilities operated by Centinel Spine, LLC

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. “CENTINEL SPINE, LLC (FEI 3007494564) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007494564-centinel-spine-llc/

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