Device product

Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

Z-1122-2022

March 31, 2022

Class II

Product summary

Firm: Olympus Corporation of the Americas
Event: Event 90009
Status: Terminated
Classification: Class II
Quantity: 1386 units
Official record key: device-enforcement:Z-1122-2022

Official wording

Reason: Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps

Code information: Lot numbers since January 2017. Affected Lot Numbers: 01K 02K 03K 04K 05K 06K 07K 08K 09K 0XK 0YK 0ZK 11H 11K 12K 13K 14K 15K 16K 17K 18K 19K 1XK 71K 72K 73K 74K 75K 76K 77H 77K 78K 79K 7XK 7YK 7ZK 81K 82K 83K 84K 85K 86K 87K 88K 89K 8XK 8YK 8ZK 91K 92K 93K 94K 95K 96K 97K 98K 99K 9XK 9YK 9ZK

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps