FDA Device recall Z-1806-2013
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in…
- FDA Device
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in… by Aesculap, citing aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1806-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-18 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | MI, NV |
Product
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
Reason
Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. The device is labeled correctly, only the etching of the implant may be incorrect.
Identifiers
| code_info | Part no. SN038P, batch number 51915765 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Aesculap
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FDA Device · Class II · 2026-03-11 · Aesculap - Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Desc…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description…
FDA Device · Class II · 2025-11-05 · Aesculap
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1806-2013%22
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