Agency classClass IIOur severity:Severe FDA (Devices)·Z-2254-2014·Announced 2014-08-27

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.

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. 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
Category: Medical Device — Orthopedic Implants
Hazard: material-degradation
oxidation
packaging-defect
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 →

Same manufacturer · Ortho Development Corporation

See all →

Moderate
Ortho Development Recalls Tibial Tray Components Due to Manufacturing Defect
FDA (Devices) · 2020-05-13
High
Ortho Development Recalls Tibial Tray Due to Manufacturing Defect
FDA (Devices) · 2020-05-13
High
Ortho Development Recalls Pivot Bipolar Cups Due to Sealing Defects
FDA (Devices) · 2014-08-27
High
Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Seals
FDA (Devices) · 2014-08-27
High
Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches
FDA (Devices) · 2014-08-27

Same hazard · material degradation