MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error
Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.
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: This is an FDA Class II recall involving a surgical handpiece with a manufacturing defect affecting calibration-related constant values. No illnesses or injuries have been reported in the source text. Per the rubric, Class II recalls without reported harm and with unspecified hazards are typically scored as Moderate (2).
Plain-English summary
Howmedica Osteonics Corp. is recalling the MAKO Integrated Cutting System (MICS) Handpiece, Catalog Number 209063. The recall affects 897 units that were distributed worldwide, including throughout the United States, Australia, and Germany.
Stryker identified an issue with the characterization process used during manufacturing. This process error resulted in incorrect constant values being assigned to the affected handpieces. The specific serial numbers affected are listed in the FDA recall notice.
Health care facilities and providers that use or have used the MICS Handpieces should contact Howmedica Osteonics Corp. immediately. Affected units can be identified by serial number and GTIN code 00848486030193.
The recalled product
- Product
- MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 897
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)
- GTIN: 00848486030193
Distribution
Distributed nationwide across the United States.
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