AVS Anchor-C Cervical Cage Instructions for Use Labeling Correction
Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.
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: Class II labeling correction with no reported adverse events or injuries. The removal of indications language from device instructions is a documentation issue consistent with minor labeling errors per the severity rubric.
Plain-English summary
The AVS Anchor-C Cervical Cage System Instructions for Use (IFU), electronic revision 5, is being recalled by Stryker Spine. This device is used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
The recall was issued because specific language describing the indications for use applicable to the United States and Canada was inadvertently removed from the electronic instructions. Approximately 8,589 units have been distributed worldwide, including to the US and Canada, since January 2023.
Healthcare providers should verify they have the updated electronic IFU revision 5 with the complete indications language for their jurisdiction and review it before performing cervical fusion procedures with this device.
The recalled product
- Product
- AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
- Manufacturer
- Stryker Spine
- Hazard
- labeling-error
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 (1)
- electronic eIFU (revision 5) Rev 5 available January 2023 to present.
Distribution
Distributed nationwide across the United States.
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