CLASS II Device recall · Reported 19 Sep 2012 · FDA Enforcement Report
Enduramesh Corpectomy Spacer System recalled by Lucero Medical
Lucero Medical is recalling Enduramesh Corpectomy Spacer System, distributed nationwide in the US. The recall was initiated on 15 Jul 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2368-2012
- FDA event ID
- 62926
- Recalling firm
- Lucero Medical, Independence, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jul 2012
- FDA classified
- 11 Sep 2012
- Reported
- 19 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 15 Jul 2012 | Recall initiated by company | |
| 11 Sep 2012 | Classified by FDA | +58 days |
| 19 Sep 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Which lots are affected?
Part #-Lot # (s): 762.010L-110738; 762.013L-110738; 762.017L-60611, 90611, and 512171; 762.019L-60611, 90611, 100308, 1261901, and 20121901; 762.021L-60611, 90611, 100308, 110106, 20122101, and 20122102; 762.023L- 90611, 100209, 100218, 00706, 10709, 20122301, and 20122302; 762.025L-90611, 100218, 110106, 20122501, and 20122502; 762.027L-60611, 90611, 100706, and 20122071; 762.029L-90611, 1262901, and 90611; 762.031L-1263101; 762.033L-90611, 91002, and 1263301; 762.041L-90611 and 1264101; 762.043L-90611 and 1264301; 762.045L-90611; 762.047L-90611; 762.049L-90611; 762.051L-90611 and 512511; 762.053L-90611; 762.090L-90611; 762.090L-2.0-100206 and 100342; 762.090L-2.5-100206; 762.159L-110505; 762.237L-91002; 762.243L-91018; 762.270L-91018; 762.290L-91018; 762.731L-91018; 762.735L-91002; 762.767L-91018; and 762.790L-91018.
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |