Stryker Recalls Hoffmann LRF Hexapod Software Due to Calculation Error
Stryker GmbH is recalling 233 units of Hoffmann LRF Hexapod Software because it may compute erroneously accelerated correction plans under specific settings.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that results in an erroneously accelerated treatment plan. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker GmbH is recalling 233 units of Hoffmann LRF Hexapod Software, catalog number 983031, software versions HLRF 1.0-2/002 and HLRF 1.1-2/002. The recall is nationwide.
The software contains a defect that occurs when a user creates a correction plan with the 'Correct Axial First' button selected and the 'No. of corrections per day' set to more than 1. In these specific instances, the software computes an erroneously accelerated correction plan for the axial portion of the treatment plan.
Healthcare providers and patients using this software should contact Stryker GmbH for further instructions on how to address the software defect.
The recalled product
- Product
- Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
- Manufacturer
- Stryker GmbH
- Affected units
- 233
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 (2)
- Version #: HLRF 1.0-2/002
- HLRF 1.1-2/002
Distribution
Distributed nationwide across the United States.
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