Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing
Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and 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, and the hazard involves the substantial degradation of medical implant material properties due to oxidation, which poses a significant risk of injury or failure during surgical procedures.
Plain-English summary
Ortho Development Corporation is recalling specific lots of Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert components. These products are UHMWPE components used in total knee arthroplasty (TKA) procedures to serve as tibial bearing surfaces for articulation with the femoral component.
The recall was initiated because the foil pouches used to package these implants did not properly seal. This defect allowed air to seep back into the pouch after sealing, which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
The affected products were distributed worldwide, including the United States and Japan. The source text does not specify the exact number of units affected or the specific lot numbers for all product types, though it notes that no military, government, or VA consignees were involved. Consumers and healthcare providers should check their inventory against the specific product names and verify the packaging integrity of these implants before use.
The recalled product
- Product
- Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
- Manufacturer
- Ortho Development Corporation
- Affected units
- 13
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 (13)
- UC Tibial Insert Sz 3 10mm
- Part 163-3310
- Lot A136109
- UC Tibial Insert Sz 4 8mm
- Part 163-3408
- Lot A135948
- UC Tibial Insert Sz 4 14mm
- Part 163-3414
- Lot A136110
- UC Tibial Insert Sz 6 7mm
- Part 163-3607
- Lot A136113
- Lot A136746
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
Same manufacturer · Ortho Development Corporation
See all →- ModerateOrtho Development Recalls Tibial Tray Components Due to Manufacturing Defect
FDA (Devices) · 2020-05-13
- HighOrtho Development Recalls Tibial Tray Due to Manufacturing Defect
FDA (Devices) · 2020-05-13
- HighOrtho Development Recalls Pivot Bipolar Cups Due to Sealing Defects
FDA (Devices) · 2014-08-27
- HighOrtho Development Recalls Knee Implants Due to Improper Foil Pouch Seals
FDA (Devices) · 2014-08-27
- HighOrtho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches
FDA (Devices) · 2014-08-27
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