Zimmer, Inc. — Class II: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Cat
Zimmer, Inc. has initiated a Class II recall for the Off-Axis Comprehensive Shoulder System Reamer Guide (Medium, Augment). The action follows five reports of the plastic guides catching and subsequently breaking during the reaming procedure.
This recall affects Zimmer, Inc., surgical facilities utilizing the Comprehensive Shoulder System, and orthopedic surgerical teams. Regulatory and Quality departments managing Class II orthopedic instrumentation are also impacted.
The breakage of surgical guides during reaming presents a potential risk of intraoperative complications or debris. While the source does not detail clinical consequences, this event suggests a possible technical limitation in the material performance of the plastic guides under operational stress. Regulatory teams may need to assess if this indicates a trend in instrumentation durability that requires broader design or material verification.
Quality teams should prioritize the evaluation of surgical instrumentation durability, specifically regarding plastic components used in high-torque environments like reaming. Immediate action includes identifying and isolating affected catalog numbers and verifying if similar failure modes are present in other reaming guide materials or sizes.
Class II. Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.. Product: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241. Firm: Zimmer, Inc. (Warsaw IN United States). Status: Ongoing.
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