Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1031-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HATCP FEM F-L MINUS CR-FLX POR HATCP FEM F-R MINUS CR-FLX POR HATCP FEM G-L MINUS CR-FLX POR HATCP FEM G-R MINUS This device is indicated for patients with severe knee pain and disability

Product Classification:

Class II

Date Initiated: November 29, 2017

Date Posted: March 21, 2018

Recall Number: Z-1031-2018

Event ID: 78706

Reason for Recall:

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.

Status: Terminated

Product Quantity: 13,227 in total

Code Information:

65-5952-013-05 61819644 65-5952-013-05 61855471 65-5952-013-05 11004433 65-5952-013-06 62056868 65-5952-014-05 61782591 65-5952-014-05 11003623 65-5952-014-05 61987912 65-5952-014-05 62104150 65-5952-014-06 61835232 65-5952-014-06 62038826 65-5952-014-06 62132128 65-5952-015-05 61782592 65-5952-015-05 61822359 65-5952-015-05 61857405 65-5952-015-05 11004436 65-5952-015-05 61939607 65-5952-015-05 62020177 65-5952-015-05 62046101 65-5952-015-05 62122758 65-5952-015-06 61805662 65-5952-015-06 11003505 65-5952-015-06 61848476 65-5952-015-06 11004261 65-5952-015-06 61921288 65-5952-015-06 61968654 65-5952-015-06 62001382 65-5952-015-06 62025672 65-5952-015-06 62074886 65-5952-015-06 62128161 65-5952-016-05 61801433 65-5952-016-05 61836563 65-5952-016-05 61857407 65-5952-016-05 11004258 65-5952-016-05 11004438 65-5952-016-05 61928636 65-5952-016-05 61951539 65-5952-016-05 62020178 65-5952-016-05 62056869 65-5952-016-05 62092424 65-5952-016-05 62139313 65-5952-016-06 61777547 65-5952-016-06 61822354 65-5952-016-06 61857408 65-5952-016-06 11004434 65-5952-016-06 61904112 65-5952-016-06 61939609 65-5952-016-06 62002454 65-5952-016-06 62020219 65-5952-016-06 62062056 65-5952-016-06 62104151 65-5952-017-05 61824510 65-5952-017-05 61893908 65-5952-017-05 61939612 65-5952-017-05 62005729 65-5952-017-05 62025675 65-5952-017-05 62086012 65-5952-017-05 62132131 65-5952-017-06 11003018 65-5952-017-06 61795937 65-5952-017-06 61822355 65-5952-017-06 11003671 65-5952-017-06 61861698 65-5952-017-06 61846121 65-5952-017-06 11004260 65-5952-017-06 61915980 65-5952-017-06 61987914 65-5952-017-06 62020182 65-5952-017-06 62038827 65-5952-017-06 62105368

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.

Voluntary or Mandated:

Voluntary: Firm initiated