Z-1242-2024 Class II Ongoing

Recalled by Synthes (USA) Products LLC — West Chester, PA

Recall Details

Product Type
Devices
Report Date
March 13, 2024
Initiation Date
January 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 units

Product Description

Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S

Reason for Recall

Products not sterilized, sterility cannot be confirmed

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

Code Information

UDI: 07611819318489 Lot Number: 427P153