Reported Mar 21, 2018 · Terminated
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION FEMORAL F-L LPS-FLEX OPTION FEMORAL F-R LPS-FLEX OPTION FEMORAL G-L LPS-FLEX OPTION FEMORAL G-R This device is indicated for patients with severe knee pain and disability
- Lot codes and dates
2,608 of 2,608 codes
00-5964-014-516217176700-5964-014-526180472300-5964-014-526180472400-5964-014-526180472600-5964-014-526180472500-5964-014-526181176700-5964-014-526181176800-5964-014-526181282000-5964-014-526181474600-5964-014-526181474900-5964-014-526181475000-5964-014-526181474700-5964-014-526181475100-5964-014-526181569500-5964-014-526182904600-5964-014-526183227200-5964-014-526183227300-5964-014-526183227400-5964-014-526183968900-5964-014-526183969100-5964-014-526184765300-5964-014-526184765400-5964-014-526184765500-5964-014-526186020400-5964-014-526186020300-5964-014-526186020500-5964-014-526186020600-5964-014-526186669300-5964-014-526186984300-5964-014-5261870709
- Amount recalled
- 13,227 in total
This recall covers 59 products
The agency filed one notice per product. You are reading one of them; the other 58 are below.
46 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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