Z-0809-2016Class II

Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device

Name: Z-0809-2016 Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device
Creator: Exactech, Inc.
Published: 2015-09-28
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2015-09-28 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated... on 2015-09-28. FDA classified it as Class II and gives the reason as "Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0809-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-28
Posted: 2016-02-13
Terminated: 2017-03-01
Recalling firm: Exactech, Inc.
Product: Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Reason for recall: Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610)
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Exactech sent a recall notification letter dated September 28, 2016 to their only 2 consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately cease distribution or use of these products, extend this information to accounts that have this products in their possession, identify and quarentine any of the product and complete and return the attached recall inventory response form to Exactech. Contact: Kaya Davis at [email protected] or 1-800-392-2832
Quantity in commerce: 19 pieces
Distribution: US distribution in the state of FL and PA.
Product codes and lots: Catalog # 05-090-02-1610 // Expiration 07/2023 Serial #'s: 4053365, 4053366, 4053367, 4053368, 4053369, 4053370, 4053371, 4053372, 4053373, 4053374, 4053375, 4053376, 4053377, 4053378, 4053379, 4053380, 4053381, 4053382, and 4053383

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0809-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0809-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-12

Product code OVE

K132582Class IIExactech Acapella One Cervical Spacer SystemExactech, Inc. / cleared 2014-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)