Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with

FDA device recall Z-0635-2010 · posted 2010-01-14 · Terminated

Recall details

Recalling firm

Gyrus ACMI Corporation

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.

Action taken

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

Status

Terminated

Product code

GEI

Quantity affected

93,665 total (63,418 US, 30,247 OUS)

Distribution

US and International distribution. OUS to Include: Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece ,

Date initiated

2009-08-18

Date posted

2010-01-14

Date terminated

2012-03-06

Location

Southborough, MA

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