Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings
Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.
What this means for you
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 with a defect that could lead to improper surgical alignment, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Omnilife Science Inc. is recalling 15 units of the Offset Femoral Alignment Guide (Product Code: KS 67022). The recall affects specific lots identified by the numbers MM0314R, VA0713, and Z1111. The product is designed to facilitate bone preparation and implantation for the Apex Knee or Apex Hip Systems.
The recall was initiated because the markings on both versions of the alignment guides are incorrect. Specifically, the markings are reversed from the intended position, which is necessary to provide proper alignment for offset revision stems when used with the femur.
The affected products were distributed worldwide, including in the United States (specifically in Oklahoma, Colorado, Ohio, and Massachusetts) and in Spain and Australia. Healthcare providers and facilities that have received these specific lots should stop using the devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
- Manufacturer
- Omnilife Science Inc.
- Affected units
- 15
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 (3)
- Lot Numbers: MM0314R
- VA0713
- Z1111
Distribution
Part of a larger recall action
This product is one of 2 recalled by Omnilife Science Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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