Recall Z-0157-2016— Smith & Nephew, Inc., Endoscopy Div.

Name: FDA recall Z-0157-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-10

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., Endoscopy Div., initiated 2015-09-10, terminated 2021-06-23. It names one FDA 510(k) clearance: K964215. Product: Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.. Reason: Sterility of device is compromised due to breach in the packaging.

Recalling firm: Smith & Nephew, Inc., Endoscopy Div.
Classification: Class II
Status: Terminated
Initiated: 2015-09-10
Terminated: 2021-06-23
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K964215 — ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEMSmith & Nephew Endoscopy, Inc.·cleared 1996-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.