FDA (Devices) recall action 94276

Zimmer, Inc. recalled 21 products on 2024-05-08

The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products: 21
Announced: 2024-05-08
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–21 of 21

HighFDA (Devices)··2024-05-08
Zimmer Distal Lateral Fibular Plate Recall: Locking Screw Malfunction Risk
Zimmer orthopedic plates may have thread defects preventing locking screws from properly securing to the implant. This could delay surgery or cause loss of fixation requiring additional intervention.
Product
ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-14
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
ZPLP Distal Lateral Fibular Plates: locking screws may not secure
Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.
Product
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
ZPLP Distal Lateral Fibular Plates Recalled for Defective Threading
Zimmer surgical plates may have thread defects that prevent screws from properly locking, potentially causing loss of surgical fixation. Affected devices were distributed worldwide; healthcare providers should verify lot numbers against the FDA recall notice.
Product
ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-10
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Fibular Plate Recall: Defective Locking Hole Threading
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to defective threading in the locking holes. The screws may not properly engage with the plate, potentially causing surgical delays or loss of bone fixation.
Product
ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Locking Plate System Recalls Distal Fibular Plates Due to Thread Defect
Zimmer recalls distal fibular plates with defective locking holes that may prevent proper screw fixation during orthopedic surgery, potentially requiring additional intervention.
Product
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-06
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Periarticular Locking Plates Recalled for Potential Loss of Surgical Fixation
Zimmer recalled certain Periarticular Locking Plates due to a thread form defect that may prevent locking screws from properly seating. The defect may result in loss of fixation or delayed surgery requiring additional intervention.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-06
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Periarticular Locking Plate May Fail to Secure Fracture Fixation
Zimmer's periarticular locking plates may fail to properly secure surgical fixation due to a thread-form defect. The defect could result in loss of fixation requiring further surgical intervention.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-16
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer ZPLP Fibular Plate May Fail to Lock Properly During Surgery
The ZPLP Distal Lateral Fibular Plate may have a thread defect preventing screws from locking properly, potentially compromising surgical fixation and requiring further intervention.
Product
ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Periarticular Locking Plate recalled for improper screw mating defect
Zimmer, Inc. is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect that may prevent locking screws from properly mating with the plate, potentially causing surgical delays or loss of fixation.
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
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Periarticular Locking Plate screw-mating defect risks surgical fixation loss
Zimmer's Periarticular Locking Plate System has a thread defect that may prevent proper screw locking, potentially causing loss of surgical fixation. Affected units distributed worldwide.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-12
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Distal Lateral Fibular Plate may fail to lock screws securely
Zimmer's Distal Lateral Fibular Plate has threading defects that may prevent screws from locking properly. The defect could go unnoticed during surgery and cause loss of fixation.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Distal Lateral Fibular Plates May Have Improper Screw Locking
A thread form defect in the locking holes of Zimmer surgical bone plates may prevent locking screws from securing properly, potentially causing loss of fixation during surgery.
Product
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Periarticular Locking Plate System Screw-Locking Defect Recall
Zimmer is recalling Periarticular Locking Plate System Distal Lateral Fibular Plates due to threading defects that may prevent locking screws from properly mating. This could result in loss of fixation and need for additional surgery.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-12
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Distal Lateral Fibular Plate Locking Screw Defect
Zimmer's Periarticular Locking Plate may have defective locking holes that prevent screws from properly locking, risking loss of bone fixation and requiring additional surgery.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-10
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Periarticular Locking Plate System recalled due to faulty screw threads
Zimmer recalls Periarticular Locking Plate System devices due to thread defects that may prevent proper screw locking and cause surgical delay or loss of fixation.
Product
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-10
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Distal Lateral Fibular Plate Recall Due to Locking Thread Defect
Zimmer recalls certain ZPLP Distal Lateral Fibular Plates due to thread form defects in locking holes that may prevent proper screw fixation. Affected devices may lose fixation, potentially delaying surgery or requiring additional intervention.
Product
ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Distal Lateral Fibular Plate may fail to lock properly
Zimmer orthopedic plates may have thread defects preventing locking screws from properly mating, potentially resulting in loss of fixation and need for additional surgery.
Product
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Fibular Plate Recall: Locking Hole Thread Form Defect
Zimmer is recalling certain ZPLP Distal Lateral Fibular Plates due to a thread form issue in the locking holes. Improperly mating screws may not correctly lock, potentially resulting in loss of fixation and need for additional surgery.
Product
ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-08
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer surgical fracture plates may fail to lock properly
Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation requiring additional intervention.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-04
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Periarticular Locking Plate threading defect may compromise surgical fixation
Zimmer's Periarticular Locking Plate System may have defective threads in locking holes, preventing secure screw mating. The defect could result in loss of surgical stability and require additional surgery.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-08
Category
Distribution
0 states
HighFDA (Devices)··2024-05-08
Zimmer Locking Plate System recalled due to thread mating defect
Zimmer is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect in the locking holes. Locking screws may not properly mate with the plate, potentially causing surgical delay or loss of fixation.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-16
Category
Distribution
0 states