Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is… — Class II medical device recall Z-2368-2012
Terminated recall by Lucero Medical LLC, reported 2012-09-19, distributed nationwide. The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the p
| Recall number | Z-2368-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lucero Medical LLC, Independence, OH, United States |
| Recall initiated | 2012-07-15 |
| Classified | 2012-09-11 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2013-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 169 |
| Lot numbers | 00706, 100209, 100218, 100308, 100342, 100706, 10709, 110106, 1261901, 1262901, 1263301, 1264101, 1264301, 20121901, 20122071, 20122101, 20122102, 20122301, 20122302, 20122501, 20122502, 512171, 512511, 762.010L-110738, 762.013L-110738, 762.017L-60611, 762.019L-60611, 762.021L-60611, 762.023L, 762.025L-90611, 762.027L-60611, 762.029L-90611, 762.031L-1263101, 762.033L-90611, 762.041L-90611, 762.043L-90611, 762.045L-90611, 762.047L-90611, 762.049L-90611, 762.051L-90611 and 15 more |
Product
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Reason for recall
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
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-2368-2012. 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.