5 things to know - DePuy Synthes recalls devices used in spine fixation systems
Johnson & Johnson's DePuy Synthes is voluntarily recalling its USS II Polyaxial 3D heads, according to an urgent field safety notice issued out on Nov. 11.
Five 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.
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