Recall Z-1716-2025
Integra LifeSciences Corp. (NeuroSciences) · initiated April 11, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Codes / lots: Model No. 261221; UDI 10381780513599; Lot No. Lot Number, 5580821, 5664307, 6347547, 6566289, 6589889, 6715286, 6715287, 6756578, 6756631, 6757665, 6899419, 6910166, 7008982, 7008995, 7009033, 7009035, 7009166, 7009167, 7092837, 7093002, 7124525, 7195332, 7195376, 7195380, 7230293, 7230295, 7230296, 7230430, 7230431, 7230437, 7230439, 7230440, 7230441, 7230442, 7230443, 7230444, 7230445, 7230446, 7230447, 7230448, 7230449, 7230450, 7230451, 7230452, 7230453, 7230454, 7230455, 7230456, 7230457, 7230458, 7230459, 7230460, 7230461, 7230462, 7230463, 7230464, 7230465, 7230466, 7230467, 7230468, 7230471, 7230472, 7230473, 7230474, 7230475, 7230476, 7230477, 7230478, 7230479, 7230480, 7230481, 7230482, 7230483, 7230484, 7230485, 7230486, 7230487, 7230488, 7230489, 7230490, 7230491, 7230492, 7230493, 7230494, 7230495, 7230496, 7230497, 7230498, 7230499, 7230500, 7230501, 7230502, 7230503, 7230504, 7230505, 7230506, 7230507, 7230508, 7230509, 7230510, 7230511, 7230512, 7230513, 7230514, 7230515, 7230516, 7230517, 7230518, 7230519, 7230523, 7230524, 7230525, 7230526, 7230527, 7230528, 7230529, 7230530, 7230531, 7230532, 7230533, 7230534, 7230535, 7230536, 7230537, 7230538, 7230539…
Reason for recall
Inadequate weld that can potentially cause the product to disassemble.
FDA-determined cause: Process control
Action taken
An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification, dated 4/11/25, was distributed to consignees via mail and email. Consignees are being asked to check their inventory for affected devices and immediately quarantine any product identified. Consignees are asked to complete the provided Acknowledgement Form and return it via email to FCA3@integralife.com or by fax to 1-609-750-4220; all consignees are to complete and return the form. Integra asks that the recall notification be forwarded to all users of the devices and to customers who received product that was further distributed. Distributors are to collect completed Acknowledgement Forms from their customers and provide them to the firm. Consignees with any questions can contact Customer Service at 1-800-654-2873 or by email at custsvcnj@integralife.com.
Details
- Recall number
- Z-1716-2025
- Initiated
- April 11, 2025
- Posted by FDA
- May 6, 2025
- Product code
- HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered)
- Quantity
- 170,510 units
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia…
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1717-2025 Class I | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial…Inadequate weld that can potentially cause the product to disassemble. | 04/11/2025Open, Classified |