Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Seals
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical implant) where material degradation could lead to injury, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ortho Development Corporation is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibial Insert, and CK Tibial Insert components. These products are UHMWPE components used in Total Knee Arthroplasty (TKA) procedures to serve as bearing surfaces for articulation with the femoral component.
The recall was initiated because the foil pouches containing the 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 nationwide in the United States and in Japan. The source text does not specify military, government, or VA consignees. Consumers and healthcare providers should check their inventory for the specific part numbers and lot numbers listed in the official recall notice and contact the manufacturer for further instructions.
The recalled product
- Product
- PS Tibial Insert, REF 163-1XXX 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
- 11
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 (16)
- PS Tibial Insert Size 3 8mm
- Part 163-1308
- Lot A135943
- PS Tibial Insert Size 3 9mm
- Part 163-1309
- Lot A136492
- PS Tibial Insert Size 3 12mm
- Part 163-1312
- Lot A136453
- PS Tibial Insert Size 4 7mm
- Part 163-1407
- Lot A135945
- Lot A136454
- PS Tibial Insert Size 5 9mm
- Part 163-1509
- Lot A135827
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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See all →- ModerateOrtho Development Recalls Tibial Tray Components Due to Manufacturing Defect
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- HighOrtho Development Recalls Tibial Tray Due to Manufacturing Defect
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- HighOrtho Development Recalls Pivot Bipolar Cups Due to Sealing Defects
FDA (Devices) · 2014-08-27
- SevereOrtho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing
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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