| Class 2 Device Recall Medacta GMK HINGE, Tibial Insert Fixed | |
Date Initiated by Firm | May 19, 2017 |
Date Posted | June 12, 2017 |
Recall Status1 |
Terminated 3 on May 29, 2018 |
Recall Number | Z-2661-2017 |
Recall Event ID |
77467 |
510(K)Number | K130299 |
Product Classification |
Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
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Product | Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO |
Code Information |
Lot # 163646 |
Recalling Firm/ Manufacturer |
Medacta Usa Inc 3973 Delp St Memphis TN 38118-6110
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For Additional Information Contact | Customer Service 312-878-2381 |
Manufacturer Reason for Recall | One lot of product does not include a screw for attachment to the tibial base
plate. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone. |
Quantity in Commerce | 4 units |
Distribution | CA, AZ, NC, Israel, France |
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 = KRO
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