FDA (Devices) recall action 63690

Zimmer, Inc. recalled 17 products on 2012-12-26

The FDA (Devices) publishes a recall like this one as 17 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 17 pages.

Products: 17
Announced: 2012-12-26
Critical: 0
Units: 4,035

Why these products were recalled

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–17 of 17

SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling 318 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
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Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Persona Knee System Tibial Sizing Plates Recalled for Perforation Risk
Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
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0 states
HighFDA (Devices)··2012-12-26
Zimmer Recalls Persona Tibial Drills to Reduce Perforation Risk
Zimmer, Inc. is recalling 135 Persona Tibial Drills and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and
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0 states
HighFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools
Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and associated tools due to a risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Broach and Related Tools
Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and related tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling Persona knee implants and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools
Zimmer, Inc. is recalling Persona Knee System tibial broaches and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Col
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Persona Knee System Recalled for Tibial Perforation Risk
Zimmer, Inc. is recalling Persona knee system tibia implants and tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Persona Tibial Sizing Plate Recalled for Perforation Risk
Zimmer, Inc. is recalling Persona Tibial Sizing Plates and related tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Drill Guide
Zimmer, Inc. is recalling 94 units of the Persona Tibial Drill Guide to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling 346 units of Persona knee system tibia implants and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
Zimmer, Inc. is recalling 518 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disord
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Distribution
0 states
SevereFDA (Devices)··2012-12-26
Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
Zimmer, Inc. is recalling 195 Persona knee system tibia implants and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Distribution
0 states