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U.S. Department of Health and Human Services

Class 2 Device Recall Meridian Angled Awl Fixed

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 Class 2 Device Recall Meridian Angled Awl Fixedsee related information
Date Initiated by FirmJune 04, 2024
Date PostedJuly 15, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2357-2024
Recall Event ID 94872
Product Classification Awl - Product Code HWJ
ProductBrand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Code Information Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H
Recalling Firm/
Manufacturer		 SEASPINE ORTHOPEDICS CORPORATION
5770 Armada Dr
Carlsbad CA 92008-4608
For Additional Information ContactMadison Ebel
760-224-0177
Manufacturer Reason
for Recall		Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
FDA Determined
Cause 2		Process design
ActionOn June 4, 2024, SeaSpine Orthopedics issued a "Urgent Medical Device Recall" Notification via E-Mail to affected consignees. SeaSpine Orthopedics ask consignees to take the following actions: We request that you return the affected part to SeaSpine s Carlsbad facility for evaluation and potential rework. To support your upcoming cases, a replacement Vu aPod Prime NM Angled Awl will be sent (PN: 33-40-1028). Additionally, please continue to utilize the loaner pool. Please use the attached label to return the inventory in your possession at your earliest convenience. Once the inventory has been returned, please acknowledge via DocuSign.
Quantity in Commerce100 units
DistributionThe product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona
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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