ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device recall
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…
Why was ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part no. SN038P, batch number 51915765
- 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…
- Recalling firm
- Aesculap, Inc.
- Quantity
- 9
- Distribution
- US Distribution including the states of NV and MI
- Recall date
- July 31, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)