Urgent Field Safety Notice Issued for all Ceramic Hip Prostheses (Smith & Nephew)

September 21, 2016 – An urgent field safety notice has been issued for all Ceramic Hip Prostheses (including femoral ball heads and acetabular cup (shell) liners/inserts) by Smith & Nephew. For more information please go to (Documentation).

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A Field Safety Notice Issued for Locking Screws Stardrive® (DePuy Synthes)

September 5, 2016 – A field safety notice (product removal) has been issued for Locking Screw Stardrive® (Ø 2.4 mm, self-tapping, length 12 mm, TAN and Ø 2.4 mm, self-tapping, length 12 mm, TAN, Sterile). The reason for the product removal is that the product has been reported to break. For more information regarding part – and lot numbers please go to (Documentation).

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An Update has been issued for Birmingham Hip Product Range (Smith & Nephew)

May 23, 2016- An update has been issued for the Medical Device Hazard Alert, originally issued in 2015, for the BIRMINGHAM HIP™ Resurfacing (‘BHR’) product range and the BIRMINGHAM HIP™ MODULAR HEAD (BHMH) System. The update includes a current summary of the information concerning the revision rates of a number of products in the BHR and BHMH Systems. For more information please go to (Documentation).

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Voluntary Recall Issued for Cortex Screw ø 4.5 mm (Synthes GmbH)

May 22, 2016 – A voluntary recall has been issued for certain lots of the Cortex Screw ø 4.5 mm due to a mix-up with the etching and labeling of the product. For more information regarding what part and lot numbers are affected, and for more information, please go to (Documentation).

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Field Safety Corrective Action Issued for Biolox Delta Ceramic Heads (Biomet)

May 10, 2016 – A field safety corrective action has been issued for some of the Biolox Delta Ceramic Heads due to a mix-up with packaging and labelling. For more information and to learn about what lots are affected please go to (Documentation).

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Field Safety Corrective Action Issued For Guiding Rod (Peter Brehm)

April 6, 2016A field safety corrective action has been issued for a guiding rod (article # 60900-66-2) manufactured by Peter Brehm. For more information and for specific serial numbers affected please go to (Documentation).

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Field Safety Corrective Action Issued for RHK Knee Bearing Implants (Biomet UK, Ltd.)

April 6, 2016A field safety corrective action has been issued for the RHK knee 16 mm bearing for 71 mm, 75 mm, and 79 mm RHK tibial tray. The reason for the recall is that certain bearings have been found to be etched with the incorrect end numerical suffix. For more information please go to (Documentation).

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Urgent Medical Device Correction Issued for Virage OCT Spinal Fixation System Closure Caps (Zimmer Biomet Spine)

March 31, 2016Additional instructions have been added to the Virage OCT spinal fixation system technique manual related to the initial insertion and the final tightening of the closure tops. For more information please go to (Documentation).

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Urgent Medical Device Recall Issued for the Endobon Xenograft Granules (Zimmer Biomet)

March 29, 2016 – A voluntary recall has been issued for the Endobon Xenograft Granules (Biomet France SARL) due to failure of passing cytotoxicity tests at 36 months of aging. For a complete list of the products affected please go to (Documentation).

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Field Safety Notice Issued on Surfix Alpha Screws (Integra)

March 29, 2016An urgent field safety notice has been issued on two of the Surfix alpha screws (Newdeal SAS, Integra) due to a partial mix-up of batches. The products affected are Surfix Alpha screw and locking screw titanium dia. 2.7 mm L.24mm-Sterile (reference: 295224S; lot number FFAZ) and Surfix Alpha screw and locking screw titanium dia. 2.7mm L.20mm-Sterile (reference: 295220S; lot number FFAY). For more information please go to (Documentation).

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