Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arth

FDA device recall Z-0157-2016 · posted 2015-10-22 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc., Endoscopy Div.

Reason for recall

Sterility of device is compromised due to breach in the packaging

Action taken

Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & Nephew's Field Action Department via email at FieldActions@smithnephew. com or fax +1-901-566-7975 to obtain a return authorization (RA) number. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.

Root cause

Package design/selection

Status

Terminated

Product code

HWE

Quantity affected

1347 units

Distribution

Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Neth

Date initiated

2015-09-10

Date posted

2015-10-22

Date terminated

2021-06-23

Location

Mansfield, MA

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