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Terminated

Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.0 or greater or G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

FDA Recall Z-0632-2010 · Posted 2010-01-14

Recalling FirmGyrus ACMI Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-08-18
Date Terminated2012-03-06
Product Quantity93,665 total (63,418 US, 30,247 OUS)

Reason for Recall

Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.

Firm Action

An Urgent Medical Device Recall letter, dated 08/15/09 was sent to customers notifying them of the issue. The letter identified affected product, asked that they cease further use, remove affected devices from stockrooms, contact Gyrus ACMI customer service for a return goods authorization and return product to Gyrus ACMI at no charge. A reply form is also asked to be returned to Gyrus ACMI via fax. Questions and requests for a Return Goods Authorization are directed to Gyrus ACMI customer service at 1-888-524-7266.

Root Cause

Environmental control

Distribution Pattern

US and International distribution. OUS to Include: Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece , Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Panama, Puerto Rico, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024286GYRUS OPEN FORCEPSGyrus Medical, Inc. · 2003-11-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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