SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip componen

FDA device recall Z-2297-2016 · posted 2016-07-28 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc.

Reason for recall

The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

Action taken

Smith & Nephew sent an Urgent Product Recall Notification letter dated July 6, 2016, to all affected consignees via email and FedEx Overnight delivery on July 6, 2016. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were asked to inspect their inventory and located any unused affected devices and quarantine them immediately, complete the Inventory Return Certification Form and fax to 1-901-566-7975 indicating the quantities that need to be returned. Consignees should contact Smith & Nephew's Field Actions Department via email at FieldActions@smith-nephew.com to obtain a return authorization (RA) number. For questions regarding this recall call 901-399-5520.

Root cause

Packaging process control

Status

Terminated

Product code

MEH

Quantity affected

185 units

Distribution

Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR

Date initiated

2016-07-06

Date posted

2016-07-28

Date terminated

2017-07-01

Location

Memphis, TN

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