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Class 2 Device Recall Opteform Allograft Disc |
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| Date Initiated by Firm |
April 26, 2019 |
| Create Date |
May 29, 2019 |
| Recall Status1 |
Terminated 3 on April 22, 2021 |
| Recall Number |
Z-1690-2019 |
| Recall Event ID |
82759 |
| 510(K)Number |
K043421
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| Product Classification |
Filler, bone void, calcium compound - Product Code MQV
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| Product |
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90 |
| Code Information |
UDI 10885862094100 Serial Numbers: T31977961, T31977962, T31977968 |
Recalling Firm/
Manufacturer |
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
|
Manufacturer Reason
for Recall |
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
|
FDA Determined
Cause 2 |
Environmental control |
| Action |
The firm initiated the recall on 04/26/2019 by electronic mail. The notice requested the consignee cease distribution of the product, notify their customers (the user), quarantine all units subject to recall in inventory, and if any units were implanted to follow-up on the patient's condition 30 days after surgery. |
| Quantity in Commerce |
3 units |
| Distribution |
OK, VA, FL |
| 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 = MQV and Original Applicant = REGENERATION TECHNOLOGIES, INC.
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