ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral bod
FDA device recall Z-1806-2013 · posted 2013-07-25 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- Reason for recall
- 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.
- Action taken
- Aesculap notified customers via email and phone on June 18, 2013, and were instructed to check their inventory and return affected product to Aesculap. Aesculap believes that the risk to patient is low. For further questions please call 1-800-234-9179.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 9
- Distribution
- US Distribution including the states of NV and MI
- Date initiated
- 2013-06-18
- Date posted
- 2013-07-25
- Date terminated
- 2014-01-13
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE (K071983) | Aesculap Implant Systems, Inc. | 2008-05-01 |