Recall Z-0025-2016 ยท HAW Neurological Stereotaxic Instrument
Integra LifeSciences Corp.
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.
| Date | Oct 6, 2015 (initiated Aug 21, 2015) |
| Status | Terminated |
| Reason | Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing. |
| Root cause | Process design |
| Action | Integra sent an Urgent-Voluntary Medical Device Recall letter dated August 19, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm instructed their customers to: 1. Review your inventory and determine if you have an UCHRAP Adapter Plate with an affected serial number listed on the next page. If you do not, it is not affected and you can continue to use it. 2. If you do have product with a serial number listed on the next page, stop using it immediately and remove it from service. 3. Complete the attached |
| Quantity | 6 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944463 | CRW-1 SYSTEM Radionics Software Applications, Inc., Oct 26, 1995 |