Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk
Stryker GmbH is recalling 867 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the medical device.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could lead to loss of stability, meeting the criteria for a Severe rating.
Plain-English summary
Stryker GmbH is recalling 867 units of the Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. The affected devices were distributed nationwide in Colorado, Florida, Maryland, Michigan, New York, Oklahoma, and Pennsylvania. The recall involves specific lot numbers, including L18239, L13690, and Y02173.
The recall is due to a manufacturing defect where the press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy in the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial or full displacement or loss of the pin, meaning the stability of the strut of the frame cannot be ensured.
The Hoffman LRF System is indicated for the treatment and fixation of various fractures and deformities in pediatric patients and adults. Because the defect may compromise the structural stability of the device, patients and healthcare providers should contact Stryker GmbH for further instructions on how to proceed.
The recalled product
- Product
- Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
- Manufacturer
- Stryker GmbH
- Affected units
- 867
Distribution
Part of a larger recall action
This product is one of 4 recalled by Stryker GmbH 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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