Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 24, 2016
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.
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 On…
Exactech, Inc. recalled Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device… - a moderate-severity action.
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device… was recalled by Exactech, Inc. in February 24, 2016. Reason: Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbod…. Check the official notice for the remedy. Verify recall #Z-0809-2016 with the FDA Devices before acting.
The recall
Exactech, Inc. issued this moderate-severity FDA Devices recall-Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbod….
- Moderate
- severity level
- Class II
- classification
- February 24, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0809-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0809-2016) was formally reported on February 24, 2016, with the manufacturer initiating the action on September 28, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Exactech, Inc. is listed as the recalling firm, operating out of Gainesville, FL. Federal records list the affected scope as 19 pieces.
The documented reason for this recall is: 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 (05-0… Distribution data in the federal record shows the product reached: US distribution in the state of FL and PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19 pieces
Related Recalls
6
3 from same agency
Product description
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.
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)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0809-2016 |
| Date reported | February 24, 2016 |
| Date initiated | September 28, 2015 |
| Recalling firm | Exactech, Inc. |
| Firm location | Gainesville, FL |
| Affected scope | 19 pieces |
| Distribution | US distribution in the state of FL and PA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0809-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Exactech, Inc.. Units affected: 19 pieces.
Why was this product recalled? ▼
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)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2016. Severity: Moderate. Recall number: Z-0809-2016.
Where was the recalled product distributed? ▼
Distribution: US distribution in the state of FL and PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0809-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 24, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.