Facility

MIACH ORTHOPAEDICS

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

Key facts

2recalls · worst Class II

1inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	3020652309
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	69 Milk Street Westborough, MA, US 01581
Registration status	Active · expires 2026
Parent company	Miach Orthopaedics (owner-operator 10082865)
Brand names	BEAR® (Bridge-Enhanced ACL Repair) Implant

Activity by year

Recalls (2)
Inspections (1)
Warning letters (1)

Devices registered here (1)

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Product code QNI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3044

Recalls & enforcement

Class IIOngoing2025-12-31
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Class IIOngoing2023-02-02
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

FDA inspections (1)

OAI2025-04-23
Official Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

FDA warning letters (1)

Warning Letter2025-08-19
Warning Letter (opens in a new tab) · Westborough Massachusetts

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Miach Orthopaedics

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. “MIACH ORTHOPAEDICS (FEI 3020652309) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020652309-miach-orthopaedics/

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