Versys 10 Inch Beaded FC REV 13.5x250mm BWD LT and RT recall
VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Why was Versys 10 Inch Beaded FC REV 13.5x250mm BWD LT and RT 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.
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?
Item Number: 00-7843-013-11 Lot Numbers: 61879448 61768680 77000811 Item Number: 00-7843-013-12 Lot Numbers: 62029061 61852818 62116481 61937672 62143765
- Product
- VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 13,227 in total
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)