BEUDAMED
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    Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HWT·February 12, 2008

    OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWT·March 9, 2005

    OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWT·March 9, 2005

    00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·October 10, 2010

    Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·October 10, 2010

    . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·October 10, 2010

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·November 19, 2013

    Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 18 mm diameter, 130 mm length, non-sterile, catalog no. 4309-18-13 (00-4309-018-13).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWT·June 16, 2006

    Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 8 mm diameter, 130 mm length, non-sterile, catalog no. 4309-08-13 (00-4309-008-13).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWT·June 16, 2006

    00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·April 1, 2011

    00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·April 1, 2011

    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·October 10, 2010

    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·October 10, 2010

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code HWT·March 28, 2014

    NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·November 19, 2013

    Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 10 mm diameter, 170 mm length, non-sterile, catalog no. 4309-10-17 (00-4309-010-17).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWT·June 16, 2006

    12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·April 1, 2011

    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWT·April 1, 2011