REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The

FDA device recall Z-1205-2014 · posted 2014-03-13 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p

Action taken

DePuy Orthopaedics sent an Urgent Information - Recall Notice dated February 24, 2014, to all affected customers. The notice identified the product, reason for the recall and potential risks associated with using the recalled product. The notice includes response cards for the US Distributors to verify they have read, understood, and are adhering to the directions given in the field communication and for hospitals where consignment inventory is removed a hospital letter is available, as needed. No hospital signatures are required. Distributors are asked to send completed distributor cards to DePuy. Product related questions should be addressed to DePuy Orthopaedics, .Sales Consultant. Clinical questions should be addressed to DePuy Scientific Information Office 1-888-554-2482; recall questions to 574-371-4917.

Root cause

Packaging

Status

Terminated

Product code

KRO

Quantity affected

134

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Isr

Date initiated

2014-02-24

Date posted

2014-03-13

Date terminated

2015-03-03

Location

Warsaw, IN

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