Date Initiated by Firm | January 12, 2018 |
Create Date | April 24, 2018 |
Recall Status1 |
Terminated 3 on May 07, 2020 |
Recall Number | Z-1512-2018 |
Recall Event ID |
79661 |
510(K)Number | K141056 |
Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
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Product | Knee Prosthesis, Sterile, Single-Use devices
Product Usage:
The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function |
Code Information |
Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A |
Recalling Firm/ Manufacturer |
Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
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For Additional Information Contact | 201-831-5000 |
Manufacturer Reason for Recall | Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box. |
FDA Determined Cause 2 | Error in labeling |
Action | Branches/Agencies notified by email on 01/16/2018 and were asked to quarantine affected devices. Notification letters and product accountability forms were sent via UPS (with return receipt) on 01/15/2018. Customer notifications were updated and sent to consignees on 03/16/2018 as the technical and medical assessments associated with the issue were completed and additional information related to potential hazards and harms were identified. |
Quantity in Commerce | 6 units of catalog 5521-B-400 |
Distribution | Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition. |
Total Product Life Cycle | TPLC Device Report |
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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 = MBH
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