Home / Recalls / Ortho Development Corporation / Z-1904-2020

Z-1904-2020 Class II Ongoing

Recalled by Ortho Development Corporation — Draper, UT

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
May 30, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29

Product Description

Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.

Reason for Recall

The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.

Distribution Pattern

US: CA, FL, OH, PA, TX, and UT. OUS: Japan.

Code Information

Lot Number: A204324

Other recalls by Ortho Development Corporation

  • Z-1903-2020 Class II — Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. (May 30, 2019)
  • Z-2255-2014 Class II — PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA p (July 11, 2014)
  • 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-2253-2014 Class II — Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a he (July 11, 2014)
  • Z-2257-2014 Class II — Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: U (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)