CODMAN Disposable Cranial Perforator 14mm Recalled Due Weld Issue
Integra LifeSciences is recalling CODMAN Disposable Perforators (14mm) due to inadequate welds that could cause disassembly during use. The affected devices have been distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. The inadequate weld could cause failure of a surgical instrument during a cranial procedure, presenting a serious safety risk even though no injuries are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the CODMAN Disposable Perforator, 14mm (Model No. 261221), a cranial surgical perforator. The recall is due to an inadequate weld that can potentially cause the product to disassemble.
The affected devices have been distributed worldwide, including the United States and Puerto Rico, as well as 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, 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, and the United Kingdom. Approximately 170,510 units are involved in this recall.
Healthcare facilities and individuals in possession of affected CODMAN Disposable Perforators should stop using these devices immediately and contact Integra LifeSciences for instructions regarding returns or replacement. Users should check lot numbers to determine if their units are among those affected by this recall.
The recalled product
- Product
- CODMAN Disposable Perforator, 14mm. Cranial perforator.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- weld-failure
- product-disassembly
- device-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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