FDA Device recall Z-0824-2017
DF Coated Integral Shaft & Stem 15x30x38
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of DF Coated Integral Shaft & Stem 15x30x38 by Stanmore Implants Worldwide, citing the recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0824-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-07 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stanmore Implants Worldwide |
| Distribution | US |
Product
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Reason
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Identifiers
| code_info | B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0824-2017%22
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