Z-1018-2018 Class II Terminated
FDA device recall Z-1018-2018 was initiated by Zimmer Biomet, Inc. on November 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 fro… The recall status is terminated (terminated April 2, 2020). Affected quantity: 13,227 in total.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- November 29, 2017
- Termination Date
- April 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,227 in total
Product Description
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
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
Item Number: 00-8114-002-10 Lot Numbers: 61744467 61762055 61783714 62249024 62249025 62250377 62250378 62257221 62257223 62261916 62261917