FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc., Endoscopy Div.: Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Recall number
- Z-0155-2016
- Recalling firm
- Smith & Nephew, Inc., Endoscopy Div.
- Product
- Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Status
- Terminated
- Initiated
- 2015-09-10
- Posted
- 2015-10-22
- Terminated
- 2021-06-23
- Reason
- Sterility of device is compromised due to breach in the packaging
- Root cause
- Package design/selection
- Action
- 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.
- Quantity
- 603 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, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela
- Lot, serial or model codes
- Lot Numbers: 50045108 50216535 50337080 50381998 50444238 50069259 50225422 50337457 50387855 50451052 50078520 50237917 50340700 50401825 50451745 50105330 50239234 50340703 50408124 50452070 50108397 50244752 50349035 50413603 50455381 50113533 50247214 50350233 50416389 50456956 50118206 50250359 50354625 50425909 50128288 50258565 50356930 50427082 50200340 50271899 50372415 50436696 50207484 50333910 50378455 50437933
- 510(k) numbers
- ["K964215"]
- PMA numbers
- not on file
- Product code
- HWE
- Firm FEI
- 1219602
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28