Z-1941-2016 Class II Terminated
FDA device recall Z-1941-2016 was initiated by Materialise USA LLC on May 3, 2016 and is designated Class II. Reason for recall: A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prio… The recall status is terminated (terminated June 28, 2016). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2016
- Initiation Date
- May 3, 2016
- Termination Date
- June 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Reason for Recall
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
Distribution Pattern
One consignee, Indiana.
Code Information
Lot #154970