BRITISH MEDICINE AND HEALTHCARE DEVICES REGULATORY AUTHORITY (MHRA) ISSUE UPDATE ON METAL-ON-METAL HIP REPLACEMENT IMPLANTS

June 30, 2017 – The MHRA’s updated recommendations now state that all patients with metal on metal hips should be followed-up. This updated guidance replaces the previous advice provided by MHRA in 2012. The stricter recommendation is welcomed by the British Orthopaedic Association (BOA) and British Hip Society (BHS). These news are receiving a lot of attention. For more information, please visit (MHRA Documentation), (Documentation), and (BOA Documentation).

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Urgent Field Safety Notice Issued for BHR Acetabular Cup (Smith & Nephew)

June 29, 2017 – Smith & Nephew are recalling several lots of BIRMINGHAM HIP Acetabular cups. The recall is due to a manufacturing issue and the affected lots are: ACETABULAR CUP HAP 56 MM W/IMPTR (product #: 7412 0156; batch # 16FW05491 & 16FW06292) and ACETABULAR CUP HAP SIZE 56/62 (product #: 7412 2162; batch #s 16FW07740; 16FW07750; and 16FW07751). For more information please go to (Documentation).

 

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Urgent Field Safety Notice Issued for Pedicle Access Kit (PAK) Needles (Medtronic)

June 29, 2017One lot number (Model 8670009, Lot Number 0521148W) of Pedicle Access Kit Needles has been recalled by Medtronic. The reason for the recall is that the packaging may contain the incorrect type of needle. For more information, please go to (Documentation).

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Urgent Medical Device Field Safety Notice Issued for Various Trauma and Extremity Instruments (Zimmer Biomet)

June 29, 2017- Zimmer Biomet is recalling various trauma and extremity instruments (drill bits and screw taps). The reason for the recall is that a raw material anomaly was detected during a medical device field action. To see the list of affected items and lot numbers please go to (Documentation).

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Urgent Field Safety Notice Issued for KYPHON® Directional Bone Filler (Medtronic)

June 29, 2017 A recall has been issued for all lot numbers of KYPHON® Directional Bone Void Filler, Product # F04C. The reason for this action is that it has been found that the directional arrow at the proximal end of the instrument might not correctly align with the cut‐out opening on the distal end of the instrument, which can result in serious consequences for the patient. For more information please go to (Documentation).

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Implantable Spinal Fusion Stimulators Recalled (Zimmer Biomet)

June 2, 2017 – The SpD PLUS-Mini and the SpF XL llb implantable spinal fusion stimulators by Zimmer Biomet have been recalled. The reason for the recall is that higher than allowed levels of chemicals, which can cause cytotoxicity, have been found in the devices. For more information please go to (Documentation).

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An Urgent Field Safety Notice Issued for Exeter Stem size 0 (Stryker)

May 31 – A lot specific urgent field safety notice has been issued for Exeter Stem size 0 (Stryker). Potential risks listed include insufficient or excessive cement mantle in the proximal-medial region and the implant loosening due to improper seating. For more information please go to (Documentation).

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Class 2 Device Recall Modular REDAPT ™ Hip System (Smith & Nephew)

May 5, 2017 – A class 2 device recall has been issued on the Modular REDAPT ™ Hip System (Smith & Nephew). All lots of modular neck hip prostheses are being recalled because of a higher than expected complaint and adverse event trend. More information can be found on US FDAs webpage (Documentation).

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Urgent Field Safety Notice Issued for Infinity-lock and Disposable Instrument Set (Xiros)

May 5, 2017 – A voluntary medical device field action has been issued for the Infinity-lock and disposable instrument set by Xiros because of higher than expected intra- and post-operative implant and instrumentation failures. For more information please go to (Documentation).

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Medical Device Field Safety Notification (product removal) Issued for the DePuy Synthes Radial Head Prosthesis System

May 5, 2017 – A removal of the DePuy Synthes Radial Head Prosthesis System has been initiated because of the possibility of loosening post-operatively at the stem bone interface. For more information please go to (Documentation).

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