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U.S. Department of Health and Human Services

Class 2 Device Recall Endo

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 Class 2 Device Recall Endosee related information
Date Initiated by FirmNovember 08, 2022
Date PostedDecember 30, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0774-2023
Recall Event ID 91236
Product Classification Instrument, manual, surgical, general use - Product Code MDM
Product9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
Code Information UDI: N/A Lot Numbers: 58672, 58673
FEI Number 2243842
Recalling Firm/
Manufacturer		 ENDO Pharmaceuticals Solutions, Inc.
8 Clarke Dr
Cranbury NJ 08512-3617
For Additional Information ContactSAME
609-409-9010
Manufacturer Reason
for Recall		No expiration dates printed on the packaging
FDA Determined
Cause 2		Incorrect or no expiration date
ActionEndo 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 devices along with the completed form are returned to: Endo Pharmaceuticals 8 Clarke Dr., Suite 6 Cranbury, NJ 08512 Attn: Trocar Market Withdrawal Returned product will be replaced by Endo Pharmaceuticals Inc. Customers who have questions or need additional information regarding this correction may contact Endo at 1-800-462-3636. If you have further distributed this product, please identify and notify your customers of this product recall. Please ensure that this notification is forwarded to all Healthcare Professionals who have received the 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants from the lots identified in Table 1 (page 3 of 5). Please let end users know to return for replacement . November 8, 2022 Endo notified the wholesaler to prevent any further distribution of the affected lots.
Quantity in Commerce2603 units
DistributionNationwide
Total Product Life CycleTPLC 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 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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