Zimmer Cryo Mini

Technical Specs

Height

650 mm

Length

600 mm

Weight

35.5 kg

Width

335 mm

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Operating rooms and surgical procedure suites
• Dermatology and medical-aesthetic clinics
• ENT, gynecology, and specialty procedure rooms
• Outpatient surgical centers

Documents & Manuals

• Zimmer Cryo Mini User's ManualUser Manual · External
• Zimmer Cryo Mini BrochureBrochure · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  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.

• RECALL

  Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

• RECALL

  The product was potentially being packaged without a taper adapter.

• RECALL

  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.

• RECALL

  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.

• RECALL

  Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

• RECALL

  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

• RECALL

  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.

• RECALL

  A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

• RECALL

  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.

• RECALL

  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.

• RECALL

  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.

• RECALL

  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.