Home / Recalls / Linkbio Corp. / Z-1536-2023

Z-1536-2023 Class II Ongoing

Recalled by Linkbio Corp. — Rockaway, NJ

Recall Details

Product Type
Devices
Report Date
May 10, 2023
Initiation Date
March 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 units

Product Description

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13

Reason for Recall

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

Distribution Pattern

NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus

Code Information

UDI-DI: 04026575436705 All lot numbers within the labeled expiration date

Other recalls by Linkbio Corp.

  • Z-1674-2023 Class II — LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5 (April 25, 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-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-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-1522-2023 Class II — LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15 (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-1538-2023 Class II — LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: (March 21, 2023)
  • 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)