Device product
ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Z-2714-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115
- Official record key
device-enforcement:Z-2714-2015
Official wording
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information: Code: 900982 Lots: 141015603 exp. 10/31/15 141216365 exp. 12/31/15 150116540 exp. 1/31/16 150116982 exp. 1/31/16 150418429 exp. 5/31/16 150317871 exp. 5/31/16 150518850 exp. 6/30/16
Distribution pattern: Distributed Only in Puerto Rico.
Derived failure modes
-
Manufacturing or process control
inadequate validation/qualification of sterilization processes
-
Sterility assurance
inadequate validation/qualification of sterilization