Facility

ANIKA THERAPEUTICS, INC.

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

Key facts

1recalls · 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)	3007093114
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	32 Wiggins Ave Bedford, MA, US 01730
Registration status	Active · expires 2026
Parent company	ANIKA THERAPEUTICS, INC. (owner-operator 9007935)
Brand names	Integrity Bone Staple Fixation System; Integrity Delivery Instrument, Bone Staple

Activity by year

Recalls (1)

Devices registered here (1)

Fastener, Fixation, Nondegradable, Soft Tissue
Product code MBI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

Class IITerminated2018-05-10
Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised.

All facilities operated by ANIKA THERAPEUTICS, 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. “ANIKA THERAPEUTICS, INC. (FEI 3007093114) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007093114-anika-therapeutics-inc/

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