Z-2729-2014Class II

Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must...

Name: Z-2729-2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must...
Creator: Instrumed International, Inc.
Published: 2014-05-30
License: https://open.fda.gov/license/

Instrumed International Inc dba Avalign German Specialty Instruments / initiated 2014-05-30 / Terminated / root cause: labeling and UDI

FDA source

Instrumed International, Inc. began a recall of Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to... on 2014-05-30. FDA classified it as Class II and gives the reason as "Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2729-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-30
Posted: 2014-09-30
Terminated: 2017-11-29
Recalling firm: Instrumed International Inc dba Avalign German Specialty Instruments
Product: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Instrumed sent an URGENT: MEDICAL DEVICE CORRECTION letters dated May 30, 2014 to all consignees. The letters advised the consignees of the new warning statements on the product Instructions For Use and an instruction to complete and return the attached Response Request Form to Instrumed International. Consignees were further instructed to extend the recall to the retail level. For questions contact Instrumed Quality Manager at 847-908-6119.
Quantity in commerce: 15 instruments
Distribution: Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Product codes and lots: 1) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Number: 070512; 2) Instrumed Item No.: 250-08700; Surgical Direct Catalog Code: SD11451.140; Lot Number: 080211; 3) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Numbers: 030112, 080212, 010113, 020113; 4) Instrumed Item No.: 250-08960; Surgical Direct Catalog Code: SD17520045.100; Lot Number: 070412; 5) Instrumed Item No.: 250-089360; Surgical Direct Catalog Code: SD175200.100; Lot Number: 030413

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2729-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2721-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2722-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2723-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2724-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2725-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2726-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2727-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2728-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2729-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2730-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30

Product code GEI

K060232Class IITrokamed Gmbh Electrosurgical Instruments & AccessoriesTrokamed GmbH / cleared 2006-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)