Medical device manufacturer, In2Bones SAS, has issued a medical device alert concerning its Pack 5 Shannon burrs lg 20mm sterile dia. 2.0 length 75mm. [Part number: G01 01511, Batches: 2007066, 2009022, 2009139, 2011063, 2012252] and Shannon burr lg 20mm sterile dia. 2.0 length 75mm [Part number: G01 01512, Batches: 2007087, 2011062]
The manufacturer is initiating a batch recall of some percutaneous burrs after receiving five customers complaints reporting perioperative breakages. This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.
Patients may experience prolonged surgery duration without clinical consequence, significant increase of the surgery duration or soft tissue/bone damage.
Affected users are advised to identify and quarantine all affected medical device.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 16 February 2021