FDA Device Entity Profile: ZIMMER, INC.

Known Identifiers & Locations

FEI Numbers 1000132037, 1000220733, 1526350, 3003714383, 3005751028, 3007963827, 3012319330, 3012392319, 3020393263, 5634

Owner Operator Numbers 1822565

Locations Covered 1228 Plan Les Ouates Geneve, CH; Dover, OH, US; Grand Rapids, MI, US; MERCEDITA, PR, US; MONTREAL, QUEBEC, CA; Mississauga Ontario, CA; Oranmore Galway, IE; Parsippany, NJ, US; Shannon Clare, IE; WARSAW, IN, US

Registered Establishments (10)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1526350	ZIMMER SURGICAL, INC.	Dover, OH, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
1822565	ZIMMER, INC.	WARSAW, IN, US	Manufacture Medical Device	View Details
2648920	ZIMMER MANUFACTURING B.V.	MERCEDITA, PR, US	Manufacture Medical Device	View Details
3005751028	Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, US	Manufacture Medical Device	View Details
3007963827	Zimmer Orthopedic Mfg Ltd	Shannon Clare, IE	Manufacture Medical Device	View Details
3012319330	Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway, IE	Manufacture Medical Device	View Details
3012392319	Zimmer Biomet Canada DFE	Mississauga Ontario, CA	Export Device to the United States But Perform No Other Operation on Device	View Details
3020393263	Zimmer U.S., Inc. Connected Health	Grand Rapids, MI, US	Manufacture Medical Device	View Details
8031000	ZIMMER SURGICAL SA	1228 Plan Les Ouates Geneve, CH	Manufacture Medical Device	View Details
9617840	ZIMMER CAS	MONTREAL, QUEBEC, CA	Manufacture Medical Device	View Details

510(k) Premarket Notifications (4)

Submission #	Device Name	Decision Date	Decision Description	Action
K040389	COONRAD/MORREY ELBOW CEMENT RESTRICTOR	2004-05-17	Substantially Equivalent	View Details
K042598	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29	Substantially Equivalent	View Details
K222566	Zimmer Persona Personalized Knee System	2022-10-17	Substantially Equivalent	View Details
K243247	Persona the Personalized Knee System	2024-10-29	Substantially Equivalent	View Details

FDA Recall History (18)

Recall #	Product Description	Initiation Date	Status	Action
Z-0007-2023	G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty Reason: The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.	2022-08-25	Open, Classified	View Details
Z-0023-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0024-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0025-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0026-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0026-2011	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details
Z-0027-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0027-2011	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details
Z-0027-2016	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. Reason: It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat	2015-08-11	Terminated	View Details
Z-0028-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605246. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0028-2011	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details
Z-0029-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605200. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0029-2011	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details
Z-0030-06	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 56 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430605256. Reason: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.	2005-08-23	Terminated	View Details
Z-0030-2011	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details
Z-0031-2011	SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details
Z-0032-2011	SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details
Z-0033-2011	SpeedLink 6.0 Transverse Connector X-Long 60-75mm, non-sterile, 1304-60XL Reason: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.	2009-01-01	Terminated	View Details

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