Z-1036-2018 Class II Terminated
FDA device recall Z-1036-2018 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
LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R LPS FEM COMP SZ G-L LPS FEM COMP SZ G-R This device is indicated for patients with severe knee pain and disability
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
00-5996-012-01 00-5996-012-02 00-5996-013-01 00-5996-013-02 00-5996-013-51 00-5996-013-52 00-5996-014-01 00-5996-014-02 00-5996-014-51 00-5996-014-52 00-5996-015-01 00-5996-015-02 00-5996-015-51 00-5996-015-52 00-5996-016-01 00-5996-016-02 00-5996-016-51 00-5996-016-52 00-5996-017-01 00-5996-017-02 LOT CODES NOT PROVIDED
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1036-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026