Ossur LP Rotate Foot System Recalled for Insecure Assembly
Ossur H / F is recalling LP Rotate Foot System prosthetic devices because short threads on the shock module may cause it to detach, leading to falls.
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 that poses a risk of falls and injury, meeting the criteria for a Severe rating.
Plain-English summary
Ossur H / F is recalling the LP Rotate Foot System, a prosthetic device used for fitting lower extremity amputations. The recall involves 2,194 units, with 1,464 distributed in the United States and 730 internationally. The affected products are sizes 25-27 (categories 1-6) with product numbers LRP062, LRF062, LRPU62, and LRFU62, all from manufacturing lot number HF141022.
The recall is due to a defect where the threads of the outer tube of the shock module are too short, resulting in insecure assembly. This defect may cause the shock module to become loose from the foot blade during use, which could cause the patient to fall.
The devices were distributed nationwide in the U.S. and to various international locations including Belgium, the United Kingdom, Germany, and Canada. Consumers should stop using the affected devices immediately and contact the manufacturer for instructions on repair or replacement.
The recalled product
- Product
- LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid…
- Manufacturer
- Ossur H / F
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 (5)
- LP Rotate
- sizes 25-27 cat.1-6. Product numbers LRP062
- LRF062
- LRPU62
- LRFU62. All from manufacturing lot number HF141022
Distribution
Distributed nationwide across the United States.
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