🍔 Food 💊 Drugs 🏥 Medical Devices
Endo-Model Replacement Plateau; Item Number: 15-2836/11; Class II

Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) 20260112 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
View Details
Endo-Model Replacement Plateau; Item Number: 15-2835/12; Class II

Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) 20260112 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
View Details
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; Class II

Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) 20260112 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
View Details
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; Class II

Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) 20260112 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
View Details
Endo-Model Replacement Plateau; Item Number: 15-0027/15; Class II

Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) 20260112 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
View Details
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; Class II

Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) 20260112 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
View Details
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X Class II

Reason: Impactor handle may be missing cross-pin

Exactech, Inc. 20260203 Ongoing
Distributed: US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
View Details
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 Class II

Reason: Impactor handle may be missing cross-pin

Exactech, Inc. 20260203 Ongoing
Distributed: US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
View Details
Penner Pacific Bathing Spa, Model Numbers 860010-1L Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
View Details
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
View Details
Page 193 of 4,030 | Showing 10 recalls
Data provided by openFDA