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MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DISPOSABLE CORING TREPHINE

FDA UDI
Biomet Orthopedics, LLC·00880304563254·

COCR RODS

FDA 510(k)
FDA Class 2 ·Orthopedic

APEX MODULAR HIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RESTORE SENSOR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 27, 2014

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·November 16, 2010

EON MINI

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 12, 2012

ACT ARTIC E1 HIP BRG 28X40MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·June 29, 2021

M2A-MAGNUM PF CUP 46ODX40ID

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 29, 2021

CER OPTION TYPE 1 TPR SLEVE -6

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code OQG·October 12, 2021

CER BIOLOXD OPTION HD 28MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code OQG·October 12, 2021

8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010

10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·July 1, 2010