Recall Z-0986-2015— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-0986-2015
Creator: U.S. Food and Drug Administration
Published: 2013-06-16

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2013-06-16, terminated 2015-08-20. It names one FDA 510(k) clearance: K060076. Product: The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.. Reason: Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-06-16
Terminated: 2015-08-20
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K060076 — SURGICOUNT SAFETY-SPONGE SYSTEMSurgicount Medical·cleared 2006-03-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.

Reason for recall

Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.