Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Recalled by Exactech, Inc. Due to Incorrect external and internal packaging labels. Exactech has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exactech, Inc. directly.
Affected Products
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.
Quantity: 19 pieces
Why Was This 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)
Where Was This Sold?
This product was distributed to 2 states: FL, PA
About Exactech, Inc.
Exactech, Inc. has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report