Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella On
FDA device recall Z-0809-2016 · posted 2016-02-13 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- 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)
- Action taken
- 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 Kaya@exac.com or 1-800-392-2832
- Root cause
- Process control
- Status
- Terminated
- Product code
- OVE
- Quantity affected
- 19 pieces
- Distribution
- US distribution in the state of FL and PA.
- Date initiated
- 2015-09-28
- Date posted
- 2016-02-13
- Date terminated
- 2017-03-01
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM (K132582) | Exactech, Inc. | 2014-02-12 |