Home / Recalls / Integra LifeSciences Corp. (NeuroSciences) / Z-1717-2025

Z-1717-2025 Class I Ongoing

Recalled by Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ

FDA device recall Z-1717-2025 was initiated by Integra LifeSciences Corp. (NeuroSciences) on April 11, 2025 and is designated Class I. Reason for recall: Inadequate weld that can potentially cause the product to disassemble. The recall status is ongoing. Affected quantity: 1,840 units.

Recall Details

Product Type
Devices
Report Date
May 14, 2025
Initiation Date
April 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,840 units

Product Description

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

Reason for Recall

Inadequate weld that can potentially cause the product to disassemble.

Distribution Pattern

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, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.

Code Information

Model No. 261230; UDI: 10381780513629; Lot No. Lot Number, 5984530, 7062002, 7062006, 7062013, 7062014, 7255930, 7255931, 7255932, 7255933, 7255934, 7255935, 7255936, 7255937, 7269522, 7269523, 7269524, 7269525, 7282944, 7282945, 7282946, 7282948, 7282949, 7282950, 7282951, 7282952, 7282953, 7293408, 7293409, 7293410, 7293411, 7293412, 7293413, 7293414, 7322892, 7322893, 7322894, 7322895, 7322896, 7322897, 7322898, 7332664, 7332665, 7332666, 7332667, 7332668, 7348744, 7348745, 7348746, 7348747, 7348748, 7371080, 7371081, 7379573, 7379576, 7379577, 7379578.

Other recalls by Integra LifeSciences Corp. (NeuroSciences)

  • Z-2714-2026 Class II — OmniTract Surgical Retractor System, which includes 633 of the firm s product co (June 5, 2026)
  • Z-2173-2026 Class II — Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product (April 10, 2026)
  • Z-1820-2026 Class II — Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. (March 19, 2026)
  • Z-1818-2026 Class II — Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. (March 19, 2026)
  • Z-1816-2026 Class II — Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. (March 19, 2026)
  • Z-1817-2026 Class II — Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. (March 19, 2026)
  • Z-1819-2026 Class II — Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. (March 19, 2026)
  • Z-1828-2026 Class II — CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical asp (March 6, 2026)
  • Z-1363-2026 Class II — MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (January 16, 2026)
  • Z-1364-2026 Class II — MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31 (January 16, 2026)

FDA data resources