Johnson & Johnson's DePuy Synthes is voluntarily recalling its USS II Polyaxial 3D heads, according to an urgent field safety notice issued out of Switzerland Nov. 11.
Six things to know:
1. The heads are part of the USS II Polyaxial System, a posterior pedicle screw fixation system designed to provide spine stabilization in skeletally mature patients. Affected devices weren't distributed in the U.S.
2. DePuy's recall comes in response to complaints about "unusual intraoperative sounds" when using the heads, as well as cracking of the device's ring.
3. Ring breakage could cause loosening of the rods, poor spinal mechanics, nonunion or malunion, pain and/or dislocation, leading to "serious" surgical delays if identified intraoperatively.
4. Surgeons should perform routine clinical follow-up and discuss potential clinical implications and risks with symptomatic patients who have the affected implants, the notice said. DePuy isn't recommending prophylactic revision for asymptomatic patients.
5. DePuy asked facilities to examine their inventory and return any affected products found.
6. A DePuy representative provided the following statement to Becker's Spine Review:
"At DePuy Synthes, our first priority is to our customers and their patients. On November 11, 2019 DePuy Synthes voluntarily issued a medical device product removal of certain lots of USS II Polyaxial 3D Heads in several markets. Affected lots were not distributed in the United States. These devices are part of a pedicle screw fixation system designed to stabilize the spine. The devices were recalled due to complaints of intra-operative sounds and cracking of the ring that helps to stabilize the spine. DePuy Synthes promptly notified relevant regulatory agencies and has begun notifying customers."