Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4 — Class II medical device recall Z-0156-2016
Terminated recall by Smith & Nephew, Inc., Endoscopy Div., reported 2015-10-28, distributed nationwide. Sterility of device is compromised due to breach in the packaging
| Recall number | Z-0156-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA, United States |
| Recall initiated | 2015-09-10 |
| Classified | 2015-10-22 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2021-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CN, DE, ES, FI, FR, GB, GR, HU, IN, IT, JP, KR, LT, LV, NL, PL, PT, SE, TH, TR, UA, VE |
| Quantity | 1,287 units |
| Reason classes | sterility |
| Model numbers | 7209235 |
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.
Reason for recall
Sterility of device is compromised due to breach in the packaging
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0156-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.