Z-0155-2016Class II

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234

Name: Z-0155-2016 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234
Creator: Smith & Nephew, Inc., Endoscopy Div.
Published: 2015-09-10
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2015-09-10 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc., Endoscopy Div. began a recall of Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open... on 2015-09-10. FDA classified it as Class II and gives the reason as "Sterility of device is compromised due to breach in the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0155-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-10
Posted: 2015-10-22
Terminated: 2021-06-23
Recalling firm: Smith & Nephew, Inc.
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.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: Sterility of device is compromised due to breach in the packaging
Root cause tag: packaging
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0155-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0155-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-22
Z-0156-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-22
Z-0157-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-22
Z-0158-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-22

Product code HWE

K964215Class IIAcufex Mosaicplasty Comprehensive SystemSmith & Nephew Endoscopy, Inc. / cleared 1996-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)