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Recall Observatory FDA recall evidence

Device product

LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device is indicated for patients with severe knee pain and disability

Z-1037-2018

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-1037-2018

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: 00-5994-013-91 61758275 00-5994-013-92 61758283 00-5994-014-92 61768114 00-5994-014-92 11004374 00-5994-014-92 11004966 00-5994-014-92 11006826 00-5994-015-91 11003022 00-5994-015-92 61771825 00-5994-015-92 61771822 00-5994-015-92 61771828 00-5994-015-92 61771826 00-5994-015-92 61771827 00-5994-016-91 61768099 00-5994-016-91 61771829 00-5994-016-91 11005670 00-5994-016-92 61768104 00-5994-016-92 61771832

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.