Z-0156-2016Class II

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235

Name: Z-0156-2016 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235
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 4.5 mm, Sterile Part Number: 7209235 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-0156-2016
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 4.5 mm, Sterile Part Number: 7209235 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: 1287 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: 50051865 50218987 50317627 50353758 50405160 50451743 50481584 50067670 50230666 50322491 50361146 50408123 50452778 S603582 50081261 50234894 50329870 50372414 50411652 50455378 50120770 50238931 50331389 50376694 50415117 50456676 50121527 50242557 50335918 50379781 50418789 50458024 50180302 50248824 50337463 50381854 50419542 50460414 50194727 50253762 50340709 50383822 50419729 50462250 50204111 50257419 50340713 50387833 50427066 50465245 50207090 50277081 50345713 50390055 50428661 50476968 50209127 50285673 50348084 50395389 50448620 50481431

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0156-2016
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)