Recall Z-0634-2010
Gyrus ACMI Corporation · initiated August 18, 2009
Product
Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. 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.
Codes / lots: all lots
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.
FDA-determined cause: Environmental control
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.
Details
- Recall number
- Z-0634-2010
- Initiated
- August 18, 2009
- Posted by FDA
- January 14, 2010
- Terminated
- March 6, 2012
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 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 , Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Panama, Puerto Rico, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
- Recalling firm
- Gyrus ACMI Corporation, Southborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0632-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0633-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0635-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0636-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0637-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |