Home / Recalls / Ortho Development Corporation / Z-2253-2014

Z-2253-2014 Class II Terminated

Recalled by Ortho Development Corporation — Draper, UT

Recall Details

Product Type
Devices
Report Date
August 27, 2014
Initiation Date
July 11, 2014
Termination Date
October 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
188

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

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.

Code Information

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 recalls by Ortho Development Corporation

  • Z-1904-2020 Class II — Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. (May 30, 2019)
  • Z-1903-2020 Class II — Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. (May 30, 2019)
  • Z-2256-2014 Class II — Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE co (July 11, 2014)
  • Z-2254-2014 Class II — Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA pro (July 11, 2014)
  • Z-2257-2014 Class II — Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: U (July 11, 2014)
  • Z-2255-2014 Class II — PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA p (July 11, 2014)
  • Z-1610-2014 Class II — PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced (April 1, 2014)