Home / Recalls / Waldemar Link GmbH & Co. KG (Corp. Hq.) / Z-3245-2024

Z-3245-2024 Class II Ongoing

Recalled by Waldemar Link GmbH & Co. KG (Corp. Hq.) — Hamburg

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
September 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 devices

Product Description

LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

Reason for Recall

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

Distribution Pattern

US Nationwide distribution in the states of FL, KS, MI, NJ, VA.

Code Information

UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135

Other recalls by Waldemar Link GmbH & Co. KG (Corp. Hq.)

  • Z-2060-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, pro (July 16, 2013)
  • Z-2073-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, pro (July 16, 2013)
  • Z-2064-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, pr (July 16, 2013)
  • Z-2065-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, pr (July 16, 2013)
  • Z-2063-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, pr (July 16, 2013)
  • Z-2075-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, pr (July 16, 2013)
  • Z-2062-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, pr (July 16, 2013)
  • Z-2066-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, pr (July 16, 2013)
  • Z-2069-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, pro (July 16, 2013)
  • Z-2079-2013 Class II — TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, pr (July 16, 2013)