Urgent Field Notice Issued for balanSys UNI convex PE inlay x/5 (Mathys)

December 7, 2016An urgent field notice has been issued for balanSys UNI convex PE inlay x/5 (5mm) (Mathys European Orthopaedics) due to the possibility of in situ inlay breakage. For more information please go to (Documentation).

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Urgent Field Notice Issued for Modular Neck Hip Prostheses of the Modular SMF™ and Modular REDAPT™ Revision Femoral Hip Systems (Smith & Nephew)

November 30, 2016An urgent field notice has been issued for the Modular Neck Hip Prostheses of the Modular SMF™ and Modular REDAPT™ Revision Femoral Hip Systems (Smith & Nephew) due to a higher than expected number of complaints and an adverse event trend. To learn about what products are affected and for more information please go to (Documentation).

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Updated Information Regarding Previous Field Safety Notice Issued for the Trident Universal Impactor/Positioner (Stryker Orthopaedics)

November 17, 2016 – Updated information is now available for the lot-specific recall issued in September 2016 for the Trident Universal Impactor/Positioner (Stryker Orthopaedics). The initial recall was related to reports of the thread length protruding past the dome of the acetabular trial or implant, which can cause harm to the patient. The updated information include instructions for risk mitigation and actions needed. For more detailed information please go to (Documentation).

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A Field Safety Notice has been issued for BIOLOX® delta Ceramic Hip Prostheses (Corin Ltd.)

November 14, 2016A field safety notice has been issued for BIOLOX® delta Ceramic Hip Prostheses (Corin Ltd.). The instructions for using the products are being revised and the products should only be used in accordance with the revised warnings and precautions. For more information please go to (Documentation).

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Field Safety Notice Initiated for LFITTM Anatomic CoCr V40TM Femoral Heads (Stryker Orthopaedics)

November 7, 2016Stryker Orthopaedics has issued a voluntary recall for certain lots of the LFITTM Anatomic CoCr V40TM Femoral Heads due to a higher than expected number of complaints related to taper lock failure. For more information regarding the specific lots affected and more information in general please go to (Documentation).

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Class I Recall of Power Tool System Battery Adaptor (DePuy Synthes)

October 4, 2016The FDA has initiated a class I recall of DePuy Synthes’ Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II (serial numbers 05.001.024 and 05.001.108). The reason for the recall is because the adaptors may produce extreme internal pressure, which, in turn, may cause the device to explode. For more information please go to (Documentation).

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Recall of ADVANCE® HA Coated Tibial Bases (MicroPort Orthopedics)

October 4, 2016A voluntary recall has been placed on all lots of ADVANCE® HA Coated Tibial Bases. The reason for the recall is a higher than expected revision rate. For more information please go to (Documentation).

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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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