Z-1057-2018 Class II Terminated
FDA device recall Z-1057-2018 was initiated by Zimmer Biomet, Inc. on Nov 29, 2017 and is designated Class II. 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… The recall status is terminated (terminated Apr 2, 2020). Affected quantity: 13,227 in total.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 21, 2018
- Initiation Date
- Nov 29, 2017
- Termination Date
- Apr 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,227 in total
Product Description
NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
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.
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.
Code Information
00-5762-016-52 Knee LPS-FLEX GSF POR FEM, F-R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1057-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026