Retiro De Equipo (Recall) de Device Recall METS

Recall

75892

Class 2

Z-0823-2017

2016-12-07

2016-12-19

Terminated

United States

2017-07-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151639

The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.