Z-1717-2025Class I

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

Name: Z-1717-2025 CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-04-11
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-04-11 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit on 2025-04-11. FDA classified it as Class I and gives the reason as "Inadequate weld that can potentially cause the product to disassemble". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1717-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-11
Posted: 2025-05-06
Recalling firm: Integra LifeSciences Corporation
Product: CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Product code: HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Reason for recall: Inadequate weld that can potentially cause the product to disassemble.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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 [email protected].
Quantity in commerce: 1,840 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, 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1717-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1716-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-06
Z-1717-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-06

Product code HBF

K073336Class IICodman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231Codman & Shurtleff, Inc. / cleared 2008-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)