The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2253-2014·Announced 2014-08-27

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.

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 3/5 (High).

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
Category
Medical Device — Orthopedic Implant
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 →

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Same hazard · oxidation

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