| Date Initiated by Firm | September 20, 2024 |
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| Date Posted | November 14, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0410-2025 |
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| Recall Event ID |
95515 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits
Model Number: MAMC204-16 |
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| Code Information |
GTIN: 10809160360767
Lot Number: 1608931
|
Recalling Firm/
Manufacturer |
AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
|
| For Additional Information Contact | SAME
757-566-3510 |
|---|
Manufacturer Reason
for Recall | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions |
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FDA Determined
Cause 2 | Process control |
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| Action | Avid Medical issued Urgent: Voluntary Medical Device Recall letter via email on 9/20/24. Letter states reason for recall, health risk and action to take:
If you received any of the batches/lots identified in APPENDIX 1, please review your inventory, and discard the entire kit.
Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.
Distributors: If any of the affected kits identified in Appendix 1 were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness.
"Complete the attached Recall Response Form and return as soon as possible.
Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com. |
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| Quantity in Commerce | 22 eaches |
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| Distribution | US Nationwide distribution. |
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| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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