Skip to content
Recall Observatory FDA recall evidence

Device product

VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Z-1021-2018

November 29, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 78706
Status
Terminated
Classification
Class II
Quantity
13,227 in total
Official record key
device-enforcement:Z-1021-2018

Official wording

Reason: 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.

Code information: Item Number: 00-7843-015-11 Lot Numbers: 62097294 11006832 62116495 61981821 Item Number: 00-7843-015-12 Lot Numbers: 62085294 11004177 62097244 61759259 62133149 61807097 77000821 61963730

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.