Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. This is a surgical instrument where device failure (plastic breakage) during a procedure could result in patient harm, and the source explicitly documents complaints of the hazard occurring. No illnesses or injuries are reported, but the risk of harm from surgical instrument failure during shoulder procedures justifies a High severity rating.
Plain-English summary
Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide (Model No. 110040241) distributed nationwide in the United States. The plastic guides in this medical device can catch during reaming, leading to breakage.
Five complaints have been received identifying this issue. The affected units include Lot Numbers 099463, 099464, 099465, and 099467, totaling 435 units distributed nationwide.
Patients or healthcare providers who have received or used this device should contact their healthcare provider or Zimmer, Inc. for further instructions. Healthcare facilities should quarantine remaining inventory and return it to Zimmer, Inc.
The recalled product
- Product
- Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
- Manufacturer
- Zimmer, Inc.
- Hazard
- device-breakage
- surgical-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot Code: Model No. 110040241
- UDI-DI (01)00889024681941(17)350602(10)099463
- Lot Number 099463 Model No. 110040241
- UDI-DI (01)00889024681941(17)350531(10)099464
- Lot Number 099464 Model No. 110040241
- UDI-DI (01)00889024681941(17)350812(10)099465
- Lot Number 099465 Model No. 110040241
- UDI-DI (01)00889024681941(17)350707(10)099467
- Lot Number 099467
Distribution
Distributed nationwide across the United States.
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