Z-0158-2016Class II

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237

Name: Z-0158-2016 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237
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 8.5 mm, Sterile Part Number: 7209237 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-0158-2016
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 8.5 mm, Sterile Part Number: 7209237 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: 1246 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: 50069280 50214249 50260936 50334160 50380067 50410625 50442600 50084563 50217938 50266144 50337465 50383809 50412120 50448621 50097669 50227860 50276674 50352665 50385382 50415177 50451051 50112174 50231228 50282533 50353524 50389835 50416603 50451744 50117989 50236270 50310331 50356943 50391478 50424410 50452069 50131406 50242373 50317889 50362696 50396029 50428473 50455380 50139181 50246739 50320168 50370396 50399036 50428686 50457280 50148410 50254144 50324084 50372214 50401621 50432549 50461109 50199543 50254145 50328908 50374300 50404803 50436553 50469462 50203454 50258249 50332285 50378312 50407329 50436675 50475144 50481307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0158-2016
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)