OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
USOmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Recalling Firm: Integra LifeSciences Corp. (NeuroSciences)
Reason for Recall / Hazard
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Product Description & Identification
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Event id | 99193 |
| Address 1 | 1100 Campus Rd |
| Address 2 | N/A |
| Code info | Product Code 3032, UDI 10381780268468; Product Code 3055, UDI 10381780268505; Product Code 3069, UDI 10381780268512; Product Code 3076, UDI 10381780268529; Product Code 3086, UDI 10381780268536; Product Code 3092, UDI 10381780268550; Product Code 3093, UDI 10381780268567; Product Code 3096, UDI 10381780268581; Product Code 3098, UDI 10381780268598; Product Code 3099, UDI 10381780268604; Product Code 3133, UDI 10381780268680; Product Code 3137, UDI 10381780268697; Product Code 3142, UDI 10381780268710; Product Code 3146, UDI 10381780268734; Product Code 3148, UDI 10381780268758; Product Code 3176, UDI 10381780268826; Product Code 3177, UDI 10381780268833; Product Code 3185, UDI 10381780268857; Product Code 3201, UDI 10381780268871; Product Code 3203, UDI 10381780268888; Product Code 3216, UDI 10381780268895; Product Code 3217, UDI 10381780268901; Product Code 3218, UDI 10381780268918; Product Code 3219, UDI 10381780268925; Product Code 3220, UDI 10381780268932; ... [TRUNCATED] |
| Postal code | 08540-6650 |
| Report date | 20260715 |
| Product type | Devices |
| Product quantity | 633 units |
| Reason for recall | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260605 |
| Initial firm notification | Letter |
| Center classification date | 20260709 |
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Overview
- Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea (the Republic of), Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands (the), New Zealand, Norway, Pakistan, Palestine, State of, Philippines (the), Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, R¿union, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Thailand, Trinidad and Tobago, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland, (the), Viet Nam.
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🚨 SAFETY ALERT: Integra LifeSciences Corp. (NeuroSciences) - OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. Check if your household is affected: https://therecallfile.com/recalls/omnitract-surgical-retractor-system-which-includes-633-of-the-firm-s-p/FDA-Z-2714-2026
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