Zimmer · Model Cryo Mini
• Easy Maintenance • Economic • Versatility • Easy Operation • Quick and Efficient Application • Noise Reducing Design • Warm up Status Indicator • Hands Free Operation
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Symptoms: Reduced output power, inconsistent treatment fluence.
Root cause: Normal diode/gain-medium wear over lamp/diode hours.
Symptoms: Overheat shutdown mid-treatment, error code on startup.
Root cause: Coolant pump, TEC element, or filter degradation.
Symptoms: Uneven beam delivery, connector arcing, or no output at the handpiece.
Root cause: Fiber or articulated-arm optics degraded by flex/heat cycling.
Symptoms: Won't fire, safety interlock fault on the display.
Root cause: Door/footswitch interlock or shutter mechanism failure.
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
High-turnover; keep spares.
Core consumable; major cost driver.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Cooling system (pump / TEC / filter) | Periodic replacement | $$$ | Moderate |
| Handpiece / delivery fiber assembly High-turnover; keep spares. | Periodic replacement | $$$ | Fairly easy |
| Footswitch / interlock assembly | Major service part | $$ | Fairly easy |
| Laser diode / flashlamp module Core consumable; major cost driver. | Periodic replacement | $$$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
The product was potentially being packaged without a taper adapter.
Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
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