Facility

LinkBio Corp.

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

Key facts

3recalls · 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)	3006721341
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	69 King Street Dover, NJ, US 07801
Registration status	Active · expires 2026
Parent company	LinkBio Corp. (owner-operator 10022893)
Brand names	LinkBio Instrument; LinkBio Instruments (Broaches, Broach guide rods)

Activity by year

Recalls (3)

Devices registered here (1)

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

Recalls & enforcement

Class IIOngoing2026-03-12
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Class IIOngoing2023-04-25
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Class IIOngoing2023-03-21
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique l…

All facilities operated by LinkBio Corp.

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. “LinkBio Corp. (FEI 3006721341) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006721341-linkbio-corp/

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