| Date Initiated by Firm | August 22, 2019 |
|---|
| Create Date | October 08, 2019 |
|---|
| Recall Status1 |
Terminated 3 on July 08, 2020 |
| Recall Number | Z-0063-2020 |
|---|
| Recall Event ID |
83760 |
| 510(K)Number | K162719 |
|---|
| Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
|
| Product | iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right |
|---|
| Code Information |
0448088 |
Recalling Firm/
Manufacturer |
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
|
| For Additional Information Contact | Paul Smolenski
781-374-5586 |
|---|
Manufacturer Reason
for Recall | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Conformis was notified of the issue on 8/22/19 when a customer reported that there had been a package mix-up. Conformis immediately contacted the customer associated with the other serial number involved in the mix-up and requested the return of that stem. Conformis is not aware of any other instances of mixed product. |
|---|
| Quantity in Commerce | 1 |
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| Distribution | Distributed to consignees in MD and NV. |
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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 = LPH
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