Recall Z-0774-2023 ยท MDM Instrument, Manual, Surgical, General Use
ENDO Pharmaceuticals Solutions, Inc.
9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
| Date | Dec 30, 2022 (initiated Nov 8, 2022) |
| Status | Open, Classified |
| Reason | No expiration dates printed on the packaging |
| Root cause | Incorrect or no expiration date |
| Action | Endo Pharmaceuticals issued Medical Device Market Withdrawal letter dated 12/8/22 to Distributor and End-Users via email/mail. Letter states reason for recall, health risk and action to take: 1. If you have any affected lots in your inventory, please immediately quarantine to prevent any further use. 2. Please complete the Market Withdrawal Acknowledgement and Receipt Form (attached below)and email to marketwithdrawal@endo.com or return by fax to 1-610-561-3085. 3. A shipping label will be mailed to the address provided on the Market Withdrawal Acknowledgement and Receipt form and any affected |
| Quantity | 2603 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.