Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY recallZ-2253-2014 · Ortho Development Corporation · initiated Jul 11, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Development Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing 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.
FDA root cause category: Packaging process control
What the company is doing
Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.
Recall details
- Recall number
- Z-2253-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 11, 2014
- Posted by the FDA
- Aug 17, 2014
- Recalling firm
- Ortho Development Corporation
- Quantity
- 188
- Product code
- KWY
- FDA submissions
- K050966
- Distribution
- Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,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,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot A136263,Pivot Bipolar Cup 22x50mm,Part 133-2250,Lot A136265,Pivot Bipolar Cup 22x51mm,Part 133-2251,Lot A136266,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136269,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136268,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136267,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136270,
Other devices under the same FDA submission
10 devices cleared under K050966 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Pivot Bipolar 133-2244Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- Pivot Bipolar 133-2251Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- Pivot Bipolar 133-2241Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2242Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2243Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2245Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2246Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2847Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2852Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2853Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 68898).
- Z-2254-2014 · TerminatedPatella 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 co…
- Z-2255-2014 · TerminatedPS 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
- Z-2257-2014 · TerminatedTibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for artic…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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