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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01113-1
Product Name/Description	Provide Protection Caps and Provide Impression Copings Provide Protection Cap CatalogueNumber : PPC484, PPC485, PPC654, PPC655 All Lots are affected Provide Impression Coping CatalogueNumber: PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, PIC655H All Lot Numbersare affected ARTG Number: 120308
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	16/11/2015
Responsible Entity	Biomet 3i Australia Pty Ltd
Reason/Issue	It has been determined that the Provide Protection Caps (PPC***) and the Provide Impression Copings (PIC***) elicit a cytotoxic response (Grade 4). The Affected Products are intended for single, short-term use. The Affected Products were also distributed within Certain Provide Abutment Placement Kits (PAK****) as well as within Certain Provide Abutment Restorative Kits (PRK***). Both the Provide Protection Caps and the Provide Impression Copings are single-use, temporary devices. If the clinician uses either of these products, the patient may experience soft tissue irritation and discomfort.
Recall Action	Recall
Recall Action Instructions	Customers are to inspect stock and quarantine affected units. Affected units should be returned to the sponsor. The sponsor is to confirm that all affected customers have reviewed the recall notice and return credit to the affected customers. This action has been closed-out on 26/08/2016.
Contact Information	1800 802 457 - Biomet 3i