Zimmer Werber Countersink Instruments Recalled Due to Material Defect
Zimmer GmbH is recalling Werber Countersink instruments because raw material defects caused device damage.
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 recall involves a medical device defect (device damage) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer GmbH is recalling specific lots of Werber Countersink instruments used in orthopedic surgery. The affected products include the Normed General Instruments 503004541 and AO 503004341, which are used to prepare space in cortical bone for micro CBS screws in Foot, Ankle, and Hand implant systems.
The recall was initiated because the devices were produced using a different raw material than intended. This material had higher hardness and higher carbon content, which resulted in device damage. The instruments are designed to be used over a guide wire to sink screw heads into bone and avoid soft tissue irritation.
A total of 138 units (297 OUS) were distributed to a single US consignee. The affected lot numbers are 13065, 13569, and 13571. Healthcare providers and facilities should stop using these specific instruments and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortic
- Manufacturer
- Zimmer Gmbh
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 (1)
- Lots: 13065 13569 13571
Distribution
Distribution scope not specified by the agency.
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