Integra CUSA excel — Class II medical device recall Z-0920-2013
Terminated recall by Integra LifeSciences Corp., reported 2013-03-20. There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for
| Recall number | Z-0920-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2013-01-07 |
| Classified | 2013-03-08 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-08-06 |
| Countries outside the US | AT, AU, BD, BE, BG, BR, CA, CH, CN, CR, CZ, DE, DO, EG, ES, FI, FR, HK, HU, ID, IE, IL, IN, IT, JP, KR, KW, LB, LK, LV, MX, MY, NL, PH, PK, PL, PT, QA, RS, SA, SG, SI, TH, TN, TW, VN, ZA |
| Reason classes | device malfunction |
| Lot numbers | 1092855, 1093129, 1100436, 1100437, 1101217, 1101328, 1103393, 1104265, 1105067, 1110311, 1110892, 1112182, 1112183, 1114112, 1114655, 1115225, 1115499, 1115500, 1120771, 1121141, 1121142, 1121383, 1121627, 1122258, 1122259, 1123049, 1130710 |
| Model numbers | 1091431, 1091679, 1091680, 1093475, 1095103, 1095416, 1095417, 1100242, 1100434, 1100435, 1101094, 1101218, 1101219, 1103104, 1103395, 1103849, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475 and 34 more |
Product
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Reason for recall
There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0920-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.