Category Archives: Alert

Field Safety Corrective Action Issued for Cementless Oxford Partial Knee Unicompartmental Knee Replacement System (Biomet UK, Ltd.)

May 5, 2017 – A voluntary field safety corrective action has been issued for the cementless Oxford partial knee unicompartmental knee replacement system (Biomet UK) because of reported tibial plateau fractures. For more information please visit (Documentation).

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

December 7, 2016 – An 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, 2016 – An 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 … Continue reading

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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 … Continue reading

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

November 14, 2016 – A 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 … Continue reading

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

November 7, 2016 – Stryker 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 … Continue reading

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

October 4, 2016 – The 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 … Continue reading

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

October 4, 2016 – A 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 … Continue reading

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