The recall stems from a complaint trend that reported unusual intraoperative sounds associated with use of the USS II Polyaxial 3D heads, as well as cracking of the device’s ring.
Intraoperative or postoperative breakage of the device’s rings could potentially result in the loosening of rods, which can cause poor spinal mechanics, non-union or malunion, pain or dislocation. If a cracked ring is identified, a serious surgical delay could occur, according to the safety notice out of Germany.
DePuy Synthes’ USS II Polyaxial 3D head is part of the USS II Polyaxial system, a posterior pedicle screw fixation system designed to stabilize the spine in skeletally mature patients.
The company said it is not recommending prophylactic revision in the absence of symptoms, but rather it recommends that surgeons perform routine clinical follow-ups and discuss potential implications and risks with patients who received the affected implants.
DePuy Synthes urged users to examine its inventory and return affected products within 30 business days. The company has reported the issue to the relevant regulatory authority.