Device product
VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Z-1026-2018
Product summary
- Event
- Event 78706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,227 in total
- Official record key
device-enforcement:Z-1026-2018
Official wording
Reason: 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.
Code information: Item Number: 00-7843-012-36 Lot Number: 62132189 Item Number: 00-7843-013-36 Lot Numbers: 62085292 62120673 Item Number: 00-7843-015-36 Lot Numbers: 61695988 62089503 Item Number: 00-7843-017-36 Lot Number: 62097290
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.
Derived failure modes
-
Unknown
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.