Synvasive 의 리콜

Recall

64810

Class 2

Z-1115-2013

2013-04-02

2013-04-15

Terminated

United States

2014-07-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117111

Various reciprocating and oscillating saw blades were incorrectly labeled. the labeling errors include: (1) the pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) the box bar code date does not match the human readable expiration date; and (3) the label incorrectly states use with zimmer/synthes handset and not the zimmer universal power system.

Zimmer sent a Urgent Device Removal letter dated April 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that received affected product from both Synvasive and from Zimmer Surgical will receive two customer letters, as each letter sets out specific item and lot numbers dependent upon distribution entity. Zimmer Distributors will also receive an e-mail notification. All notifications include a response form for both Synvasive and Zimmer distributors as well as customer consignees to account for product disposition (disposal in the field per facilities' sharps protocol). (1) Notifications will be mailed via Fed Ex to Risk Managers and Zimmer Distributors with inventory. (2) Notifications will be emailed to international geographies. (3) Notifications will be emailed all Zimmer Distributors. (4) A second Fed Ex mailing will be sent to domestic non-responding consignees. (5) Effectiveness phone calls will be made to any remaining domestic non-responding consignees. (6) If a customer reports they have further distributed the product, the secondary consignee identified will receive a notification from Zimmer. The scope of the recall is limited to certain confirmed lots which were shipped to the affected consignees. .E-mails, certified mail receipts, and telephone records will be the firm's course of action in monitoring effectiveness checks. All returns will be stored in a separate area away from regular inventory. Final disposition of returned product is yet to be determined. The firm's recall strategy appears to be adequate. For further questions please call (916) 939-3913.