Exactech Optetrak Logic CC 15mm Tibial Augment Screws Recalled for Packaging Error
Exactech, Inc. is recalling nine tibial augment screws because they were packaged one per carton instead of the required two per carton.
What this means for you
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 packaging error (missing screw in carton) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling nine Exactech Optetrak Logic CC 15mm Tibial Augment Screws. The recall was initiated because the devices were inadvertently packaged as one per carton when two per carton are required.
The affected devices are identified by Catalog No. 02-012-50-9015 and Serial Numbers 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538. These devices were distributed in California and New York.
This is a Class II recall. The source text does not report any illnesses or injuries associated with this packaging error.
The recalled product
- Product
- Exactech Optetrak Logic CC 15mm Tibial Augment Screws
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 9
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 (10)
- Catalog No. 02-012-50-9015
- Serial #'s 4739530
- 4739531
- 4739532
- 4739533
- 4739534
- 4739535
- 4739536
- 4739537
- and 4739538.
Distribution
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