Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Recall
- Recall Number
- Z-1816-2013
- Event Number
- 65669
- Firm
- Synthes USA HQ, Inc.
- FEI Number
- 3005180112
- Product Code
- KTT
- Status
- Open, Classified
- Root Cause
- Packaging
- Initiated
- October 12, 2012
- Posted
- July 29, 2013
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
Synthes sent a Urgent Notice Medical Device Recall letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is requesting that you please examine your inventory for products with the above Part and Lot number and remove them. Call Synthes at 1-800-479-6329. If you have any further questions please call 610-719-5450.
US Distribution including the states of CA, MN, NC and TN.
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