Home / Recalls / Linkbio Corp. / Z-1674-2023

Z-1674-2023 Class II Ongoing

Recalled by Linkbio Corp. — Rockaway, NJ

Recall Details

Product Type
Devices
Report Date
June 7, 2023
Initiation Date
April 25, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 units

Product Description

LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

Reason for Recall

Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

Distribution Pattern

US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX

Code Information

UDI-DI : 04026575258123 Lot Number: 1910003

Other recalls by Linkbio Corp.

  • Z-1543-2023 Class II — LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Nu (March 21, 2023)
  • Z-1552-2023 Class II — LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Num (March 21, 2023)
  • Z-1522-2023 Class II — LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15 (March 21, 2023)
  • Z-1529-2023 Class II — LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 1 (March 21, 2023)
  • Z-1531-2023 Class II — LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Numbe (March 21, 2023)
  • Z-1534-2023 Class II — LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: (March 21, 2023)
  • Z-1549-2023 Class II — LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item N (March 21, 2023)
  • Z-1512-2023 Class II — LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15 (March 21, 2023)
  • Z-1536-2023 Class II — LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 1 (March 21, 2023)
  • Z-1508-2023 Class II — LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15 (March 21, 2023)