| Date Initiated by Firm | March 22, 2021 |
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| Date Posted | May 19, 2021 |
|---|
| Recall Status1 |
Terminated 3 on February 17, 2026 |
| Recall Number | Z-1635-2021 |
|---|
| Recall Event ID |
87696 |
| Product Classification |
Bone cement - Product Code LOD
|
| Product | CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 |
|---|
| Code Information |
BATCH:2003721 |
Recalling Firm/
Manufacturer |
BIOPSYBELL S.R.L.
Via Aldo Manuzio N. 24
Via A.Manuzio n.24
Mirandola Italy
|
Manufacturer Reason
for Recall | Products labeled as sterile were distributed, but may not have been sterilized. |
|---|
FDA Determined
Cause 2 | Vendor change control |
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| Action | The firm notified two consignees with the preliminary information by email on 03/22/2021 and followed with the official notice with the complete information on 04/08/2021 to all consignees. The letter requested that the consignee cease using the affected product and contact Biopsybell or a Biopsybell representative for product return/disposal and related replacement. Distributors were directed to identify those who received the product and notify them. |
|---|
| Quantity in Commerce | 500 units |
|---|
| Distribution | US Nationwide distribution in the states MS and KY. |
|---|
| 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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