Home / Recalls / Ortho Development Corporation / Z-2256-2014

Z-2256-2014 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
13

Product Description

Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component

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

UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,

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-2257-2014 Class II — Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: U (July 11, 2014)
  • Z-2253-2014 Class II — Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a he (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-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)