| Date Initiated by Firm | April 20, 2021 |
|---|
| Create Date | May 28, 2021 |
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| Recall Status1 |
Terminated 3 on January 19, 2023 |
| Recall Number | Z-1694-2021 |
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| Recall Event ID |
87862 |
| 510(K)Number | K121297 |
|---|
| Product Classification |
Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
|
| Product | Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant. |
|---|
| Code Information |
LOT# 71541-1 |
| FEI Number |
3008262872
|
Recalling Firm/
Manufacturer |
Signature Orthopedics Pty Limited
Lane Cove W
7 Sirius Rd
Lane Cove West Australia
|
Manufacturer Reason
for Recall | Product mislabeled, with the incorrect product inside the package. |
|---|
FDA Determined
Cause 2 | Labeling mix-ups |
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| Action | On 04/20/21 the firm sent a letter to its consignee with the following instructions: examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once by forwarding this letter. Please complete the Customer Acknowledgement Form. |
|---|
| Quantity in Commerce | 3 units |
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| Distribution | US Nationwide distribution in the state of NC. |
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| 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.
|
| 510(K) Database | 510(K)s with Product Code = MEH
|
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