Device product

Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00

Z-1471-2018

March 26, 2018

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 79681
Status: Terminated
Classification: Class II
Quantity: 19483 total products
Official record key: device-enforcement:Z-1471-2018

Official wording

Reason: Potential failure of sterile packaging seal.

Code information: Lot Numbers: 63655999 63715685 63731170 63733045 63812299

Distribution pattern: US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential failure of sterile packaging seal.