Ortho Development Recalls Knee Implant Components Due to Sealing Defects
Ortho Development is recalling specific knee implant components because defective foil pouches allowed air to enter, potentially degrading the material properties of the implants.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, an FDA Class II recall involving a medical device with a defect that could lead to substantial degradation of material properties (oxidation) fits the 'Severe' category, particularly given the potential for significant injury if the implant fails in vivo.
Plain-English summary
Ortho Development Corporation is recalling specific knee implant components, including the Patella 38mm (REF164-0038), Pivot Bipolar Cup, PS Tibial Insert, UC Tibial Insert, and CK Tibial Insert. The recall is due to a defect in the foil pouches used for packaging, which did not properly seal. This failure allowed air to seep back into the pouch after sealing.
The presence of air increases the risk that the material properties of the implants would be substantially degraded due to oxidation. The affected products are UHMWPE components used in total knee arthroplasty (TKA) procedures to resurface the patella and serve as a bearing surface for sliding contact with the femoral component.
The recall involves 14 units of the Patella 38mm (Part 164-0038, Lot A135844). Distribution was worldwide, including the United States and Japan. No military, government, or VA consignees were involved. Healthcare providers and patients should contact Ortho Development Corporation for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
- Manufacturer
- Ortho Development Corporation
- Affected units
- 14
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)
- Patella 38mm Part 164-0038
- Lot A135844
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Ortho Development Corporation 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.
See all 5 products in this recall →Related recalls
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