| Date Initiated by Firm | February 08, 2016 |
|---|
| Create Date | April 05, 2016 |
|---|
| Recall Status1 |
Terminated 3 on February 14, 2017 |
| Recall Number | Z-1328-2016 |
|---|
| Recall Event ID |
73373 |
| Product Classification |
Cannula, surgical, general & plastic surgery - Product Code GEA
|
| Product | MicroAire PAL Cannula
Product Usage - Power Aspiration Device |
|---|
| Code Information |
Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334 |
| FEI Number |
2020601
|
Recalling Firm/
Manufacturer |
MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9006
|
| For Additional Information Contact |
434-975-8000 |
|---|
Manufacturer Reason
for Recall | MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery.
Accordingly, the PAL-R4011XL has also been put on production hold until further notice. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | The firm is sending letters to all customers who have received PAL-R4011XL from
August 2013- October 2015.
The firm sent these letters by UPS to expedite the delivery and for traceability. |
|---|
| Quantity in Commerce | 145 manufactured and distributed |
|---|
| Distribution | Worldwide Distribution - US Nationwide |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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