Recall Z-1452-2022— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1452-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-15

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2022-06-15, terminated 2024-04-05. It names one FDA 510(k) clearance: K060076. Product: SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.. Reason: When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2022-06-15
Terminated: 2024-04-05
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

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.

Reason for recall

When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.

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