Some of J&J subsidiary Ethicon Endo-Surgery’s Ligaclip devices are being pulled from hospital shelves on the risk of malformed clips failing to occlude the target vessel or structure, according to the TGA.
Johnson & Johnson "identified potential clip formation and feeding issues, which may result in improper clip formation and insufficient occlusion of the vessel or other structure," according to the Aussie watchdog.
The recall covers the Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier, code number "ER320," with expirations dates from November 2016 to March 2018, according to the Aussie watchdog.
"Product recall of affected units is on-going," according to the TGA.
Affected devices should be quarantined until they can be returned to J&J, according to the agency.
J&J has been in the hot seat for a while due to the high-profile recall and subsequent lawsuits over its ASR metal-on-metal hip implants.
DePuy voluntarily recalled the ASR in August 2010 "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a company report. A report passed around internally in 2011, in the midst of the high-profile recall, concluded that 37% of DePuy’s ASR hip implants would require revision or replacement in less than 4.6 years.
A spate of recalls spanning its other divisions have also bedeviled the healthcare giant in recent years.
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