Recall

Class II — Exactech, Inc.

Recalling firm	EXACTECH, INC.
Registered facility	View this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
Classification	Class II
Status	Terminated
Reason	The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.
Product	Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
Quantity	242
Distribution	USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.
Initiated	2014-01-06
Classified	2014-03-18
Terminated	2014-08-04
Recall number	Z-1217-2014
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Exactech, Inc. (Z-1217-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67486/

Not open yet

Alerts for EXACTECH, 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.