various polyethylene implants Sports Med Repicci II recall: Endotoxin
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Why was various polyethylene implants Sports Med Repicci II recalled?
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150
- Product
- various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 28,253 in total
- Distribution
- Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
- Recall date
- April 26, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)