Home / Recalls / Ortho Development Corporation / Z-2257-2014

Z-2257-2014 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: 1

Product Description

Tibila 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 articulation with the femoral component where additional joint constraint is needed

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

CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666

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-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)