Medical device manufacturer, Synthes GmbH, has issued a medical device product removal concerning its 1.0mm Cloverleaf Footplates and AB & BC Distractor Bodies. The affected part numbers are identified as follow:-
According to the manufacturer, the affected products are part of the Synthes Craniomaxillofacial (CMF) Distraction System. The CMF Distraction System is a modular family of internal distraction devices to lengthen the mandibular body and ramus. The medical device product removal is not being initiated to reduce a risk to health posed by the devices. The products subject to the action are being removed from the market to prevent any future potential incompatibility with devices being re-designed and re-introduced into the CMF Distraction System.
There is no product safety impact or risk of patient harm. Health care practitioners that have treated patients using the subject CMF Distraction System devices should continue to follow those patients as per the standard of care. Affected users should examine their inventory immediately to determine if they have product subject to the action on hand and quarantine the product.
Product removal is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 December 2019