Zimmer Biomet Compress System Surgical Technique Correction Recall
Zimmer Biomet is correcting the surgical technique for the Compress System to update selection criteria for anti-rotation pin placement.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation correction to surgical technique selection criteria, which falls under the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific Compress Devices and Instruments, including anti-rotation spindles, centering sleeves, and mini taper spindles. The recall involves 323 devices in the United States and 208 distributed outside the US to countries including Canada, Argentina, Australia, Belgium, Chile, Finland, Japan, and the Netherlands.
The reason for this recall is a correction to the surgical technique documentation for the Compress System. The update specifically addresses the selection criteria section on page 42 regarding which array to use when placing anti-rotation pins. This is a documentation correction intended to ensure users are aware of the changes to the selection criteria.
Healthcare providers and users of these devices should review the updated surgical technique to ensure the correct array is selected for anti-rotation pin placement. The recall is limited to the documentation correction and does not indicate a defect in the physical devices themselves.
The recalled product
- Product
- Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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)
- All
Distribution
Distributed nationwide across the United States.
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