Facility

BIOHORIZONS IMPLANT SYSTEMS INC.

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

Key facts

4recalls · worst Class II

2inspections · worst NAI

—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)	1000592496
Establishment type	Manufacture Medical Device
Location	2300 RIVERCHASE CENTER BIRMINGHAM, AL, US 35244
Registration status	Active · expires 2026
Parent company	BIOHORIZONS IMPLANT SYSTEMS, INC. (owner-operator 9024113)
Brand names	BioHorizons Tapered Short Implants

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

Implant, Endosseous, Root-Form
Product code DZE (opens in a new tab) · Class II · Dental · 21 CFR 872.3640

Recalls & enforcement

Class IITerminated2015-10-30
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Class IITerminated2015-04-16
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Class IITerminated2013-12-10
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Class IITerminated2012-11-19
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

FDA inspections (2)

NAI2019-03-05
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-01-29
No Action Indicated · Compliance: Devices

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.

All facilities operated by BIOHORIZONS IMPLANT SYSTEMS, 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. “BIOHORIZONS IMPLANT SYSTEMS INC. (FEI 1000592496) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000592496-biohorizons-implant-systems-inc/

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