CLASS II Device recall · Reported 28 Oct 2015 · FDA Enforcement Report

Smith & Nephew Mosaicplasty DP- Disposable Harvesting recalled

Smith & Nephew, Inc., Endoscopy Div is recalling Smith & Nephew Mosaicplasty DP- Disposable Harvesting System, Sterile, distributed nationwide in the US. The recall was initiated on 10 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled603 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0155-2016
FDA event ID: 72205
Recalling firm: Smith & Nephew, Inc., Endoscopy Div, Mansfield, MA
Classification: Class II
Status: Terminated
Recall initiated: 10 Sep 2015
FDA classified: 22 Oct 2015
Reported: 28 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

10 Sep 2015	Recall initiated by company
22 Oct 2015	Classified by FDA	+42 days
28 Oct 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterility of device is compromised due to breach in the packaging

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is Smith & Nephew Mosaicplasty DP- Disposable Harvesting System, Sterile recalled?

Yes. Smith & Nephew, Inc., Endoscopy Div recalled Smith & Nephew Mosaicplasty DP- Disposable Harvesting System, Sterile on 10 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0155-2016.

Why was it recalled?

Sterility of device is compromised due to breach in the packaging

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Smith & Nephew, Inc., Endoscopy Div

All 7

Reported	Class	Recall	Company	Reason	Where
24 Feb 2016Device	CLASS II	High Flow Irrigation Extender recalled by Smith & Nephew, Inc.	Smith & Nephew, Inc., Endoscopy Div	Packaging Defects	15 states
10 Feb 2016Device	CLASS II	Biosure Driver, Product No: 72201887 For delivery recalled	Smith & Nephew, Inc., Endoscopy Div	Device Malfunction	17 states
10 Feb 2016Device	CLASS II	Biosure Ratchet Driver, Product No recalled by Smith & Nephew, Inc.	Smith & Nephew, Inc., Endoscopy Div	Device Malfunction	17 states
28 Oct 2015Device	CLASS II	Smith & Nephew Mosaicplasty DP- Disposable Harvesting recalled	Smith & Nephew, Inc., Endoscopy Div	Sterility	Nationwide
28 Oct 2015Device	CLASS II	Smith & Nephew Mosaicplasty DP- Disposable Harvesting recalled	Smith & Nephew, Inc., Endoscopy Div	Sterility	Nationwide

Other Hip & Knee Implants recalls

All 3,097

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26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide