Ortho Development Recalls Pivot Bipolar Cups Due to Sealing Defects
Ortho Development is recalling Pivot Bipolar Cups because foil pouches failed to seal properly, allowing air to enter and potentially degrading the implant material.
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 no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ortho Development Corporation is recalling various Pivot Bipolar Cups, Patella, PS Tibial Insert, UC Tibial Insert, and CK Tibial Insert devices. The recall involves 188 units distributed nationwide in the United States and in Japan.
The recall was initiated because the foil pouches used to package these devices 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.
These devices are used in hemiarthroplasty procedures as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
- Manufacturer
- Ortho Development Corporation
- Hazard
- Affected units
- 188
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 (20)
- Pivot Bipolar Cup 22x42mm
- Part 133-2242
- Lot A136254
- Pivot Bipolar Cup 22x43mm
- Part 133-2243
- Lot A136256
- Lot A136255
- Pivot Bipolar Cup 22x44mm
- Part 133-2244
- Lot A136257
- Pivot Bipolar Cup 22x45mm
- Part 133-2245
- Lot A136258
- Pivot Bipolar Cup 22x46mm
- Part 133-2246
- Lot A136259
- Lot A136260
- Pivot Bipolar Cup 22x47mm
- Part 133-2247
- Lot A136261
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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- HighOrtho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches
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