Date Initiated by Firm | August 31, 2015 |
Date Posted | October 21, 2015 |
Recall Status1 |
Terminated 3 on March 02, 2016 |
Recall Number | Z-0138-2016 |
Recall Event ID |
72108 |
510(K)Number | K132640 K133256 |
Product Classification |
Knee arthroplasty implantation system - Product Code OOG
|
Product | ConForMIS iUni Unicondylar Knee Replacement System:
iUNI G2, Left Lateral
Catalog Number: M57220600230 (US)
M5722INT0600230 (OUS) |
Code Information |
Serial Numbers (US): 0355239 0355108 0355474 0354538 Serial Numbers (OUS): 0353919 0354845 0354849 |
Recalling Firm/ Manufacturer |
ConforMIS, Inc. 28 Crosby Dr Bedford MA 01730-1402
|
For Additional Information Contact | 781-345-9001 |
Manufacturer Reason for Recall | May contain small amounts of ethylene glycol residue |
FDA Determined Cause 2 | Process design |
Action | ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below:
Phase 1-Surgeons with product for which the surgery has not yet been completed
Phase 2-Surgeons for whom product was confirmed to have been
consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery.
Contact your local ConforMIS representative or Amita Shah, at 17813459164. |
Quantity in Commerce | 7 units |
Distribution | Distributed Nationwide and in Germany, Switzerland, and UK. |
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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510(K) Database | 510(K)s with Product Code = OOG
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