Z-1041-2018 Class II Terminated
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
CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS FEM COMP SIZE H/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
00-5972-015-01 61777593 00-5972-018-02 4002192 00-5970-012-02 61878272 00-5970-013-02 61777576 00-5970-013-02 62135909 00-5970-014-02 11400192 00-5970-014-02 62122787 00-5970-014-02 62135920 00-5970-014-02 62132399 00-5970-014-02 62132399R 00-5970-014-02 62135921 00-5970-015-02 11002229 00-5970-015-02 61777581 00-5970-015-02 62135936 00-5970-016-02 61777583 00-5970-016-02 62128113 00-5970-017-01 11003049 00-5970-018-01 61758971 00-5970-018-01 11003323 00-5970-018-02 11003330 00-5970-018-02 11003322