Exactech Acapella One Interbody Fusion Device Packaging Labeling Recall
Exactech is recalling 19 Acapella One Interbody Fusion Devices due to incorrect external and internal packaging labels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (incorrect packaging labels) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Exactech, Inc. is recalling 19 units of the Acapella One Interbody Fusion Device Parallel (Catalog # 05-090-02-1610). The recall is due to incorrect external and internal packaging labels. The devices were distributed in Florida and Pennsylvania.
The recall was initiated because 19 Acapella One Interbody Fusion Device Lordotic units (Catalog # 05-090-01-1610) were incorrectly packaged as Acapella One Interbody Fusion Device Parallel units. The affected devices have an expiration date of 07/2023 and serial numbers ranging from 4053365 to 4053383.
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. It is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach. Healthcare providers and patients should contact Exactech for further instructions regarding the return or replacement of these devices.
The recalled product
- 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…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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
Distribution
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