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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01035-1
Product Name/Description	Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95) Aequalis Reversed II Insert Impaction Handle Item Number: MWD021 Aequalis Reversed II Insert Impactor Tip Item Number: MWD023 Hemiprosthesis Adaptor Impactor Tip Item Number: MWD024 Aequalis Reversed II Anatomic Head Impactor Tip Item Number: MWD024 ARTG Number: 112287
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/10/2013
Responsible Entity	Tornier Pty Ltd
Reason/Issue	Following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, Tornier has initiated recall of all lots of Aequalis Reversed II and Reversed Fracture impactors (items number MWD021, MWD023, MWD024, MWD025). Upon Review of the event, Tornier determined that a redesign of the instrumentation was warranted. This recall action was carried out prior to approval by the Therapeutic Goods Administration.
Recall Action	Recall
Recall Action Instructions	In the interim the manufacturer (Tornier SAS) has recommended an alternative method using other impactors that are available in other Tornier shoulder instrument sets. Tornier has issued a specific operative technique to explain which impactor to be used. The replacement with new impactors has begun.
Contact Information	02 9450 1977 - Tornier Regulatory Affairs