Recall Z-1717-2024— Zimmer, Inc.

Name: FDA recall Z-1717-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-20

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2024-03-20. It names one FDA 510(k) clearance: K070906. Product: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-08. Reason: Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-20
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K070906 — MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWSZimmer, Inc.·cleared 2007-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-08

Reason for recall

Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention

Data sourced from openFDA. This site is unofficial and independent of the FDA.