Stryker Endoscopy: Medical Device Recall in 2012 - (Recall #: Z-1961-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.

Product Classification:

Class II

Date Initiated: June 19, 2012

Date Posted: July 18, 2012

Recall Number: Z-1961-2012

Event ID: 62346

Reason for Recall:

The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.

Status: Terminated

Product Quantity: 6388 units

Code Information:

All serial/lot numbers

Distribution Pattern:

Worldwide Distribution--USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated