Facility

EBI PATIENT CARE, INC.

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

Key facts

10recalls · worst Class II

2inspections · 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)	3003435252
Establishment type	Manufacture Medical Device
Location	484 Calle E GUAYNABO, PR, US 00969
Registration status	Active · expires 2026
Parent company	EBI, LLC - AHP EOS Buyer Inc. (owner-operator 2242816)
Brand names	Biomet BHS Mini; Biomet EBI Bone Healing System; EBI Bone Healing System-Model 2100; EBI Bone Healing System

Activity by year

Recalls (10)
Inspections (2)

Devices registered here (1)

Stimulator, Bone Growth, Non-Invasive
Product code LOF (opens in a new tab) · Class II · Orthopedic · 21 CFR 890.5870

Recalls & enforcement

Class IIOngoing2024-03-22
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Class IITerminated2014-11-11
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
Class IITerminated2014-10-08
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Class IITerminated2014-05-15
The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
Class IITerminated2013-09-24
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Class IITerminated2013-08-22
Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
Class IITerminated2013-08-13
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Class IITerminated2013-04-09
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Class IITerminated2013-02-07
Increased risk of failure at the driver tip during screw insertion or removal.
Class IITerminated2012-09-29
Broken screw insertor hardness was measured and found to be below the acceptable limits.

FDA inspections (2)

NAI2019-03-12
No Action Indicated · Compliance: Devices
VAI2018-01-17
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.

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. “EBI PATIENT CARE, INC. (FEI 3003435252) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003435252-ebi-patient-care-inc/

Not open yet

Alerts for EBI PATIENT CARE, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.