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MalfunctionJDQ

CABLE-READY CABLE GRIP SYSTEM, REATTACHMENT DEVICE (GTR) WITH 4 CABLES. 23 X 121

Received Mar 4, 2025 · Event occurred Nov 21, 2024

Report 21513792 · MDR key 21513792

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Product code (JDQ)
Manufacturer (Zimmer, Inc.)
Model (2232-02-05)

Device

Generic name

Cerclage, Fixation

Manufacturer

Zimmer, Inc.

Catalog number

2232-02-05

Lot number

56730164

Patient

NA · Prefer Not To Disclose

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE IMPLANT BOX HAD THE CORRECT SIZE IMPLANT NOTED ON THE EXTERIOR PACKAGING, HOWEVER, THE STICKERS ON THE INTERIOR PACKAGE WERE INCORRECT (232MM INSTEAD OF 121MM WHICH WAS THE ACCURATE SIZE). THE LOT NUMBER WAS INCORRECT (56730164 IS CORRECT, 56730158 IS INCORRECT). ZIMMER VENDOR REPRESENTATIVE ASSIGNED TO THE CASE VERIFIED THAT THIS WAS THE ONLY ONE AVAILABLE ON-SITE IN THIS SIZE.