SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, product code Surg300; Operator Manual, product code OPMA.
FDA Recall Z-0392-2010 · Posted 2009-11-23
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Recalling FirmSurgical Devices/Covidien
Recall StatusTerminated
Product CodeGDW
Date Initiated2009-09-23
Date Terminated2010-03-08
Product Quantity562 units
Reason for Recall
Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
Firm Action
The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.
Root Cause
Nonconforming Material/Component
Distribution Pattern
The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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