FDA Device recall Z-0883-2017
Savannah-T Straight Rod, 200mm, Part Number 10704-200
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Savannah-T Straight Rod, 200mm, Part Number 10704-200 by Amendia, citing the rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0883-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-22 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amendia |
| Distribution | US |
Product
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Reason
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Identifiers
| code_info | Part Number 10704-200 Lot Number 124422, 129766, 130739, 132430; Part Number 10704-250 Lot Number 129790, 130738, 131…Part Number 10704-200 Lot Number 124422, 129766, 130739, 132430; Part Number 10704-250 Lot Number 129790, 130738, 131211, 131309, 131310, 131509, 132811; Part Number 10704-300 Lot Number 129862, 134229; Part Number 10704-400 Lot Number 129861, 130145, 130147, 130502, 131499, 131646; Part Number 10704-500 Lot Number 127934, 127937, 129770, 129863, 130130, 130143, 130781, 134228; Part Number 10705-200 Lot Number 122654, 123583, 129773, 130131, 132153, 132154, 132762; Part Number 10705-220 Lot Number 128818, 131311, 132881; Part Number 10705-240 Lot Number 130500; Part Number 10705-260 Lot Number 121521, 131500, 132199; Part Number 10705-280 Lot Number 121519, 130740; Part Number 10705-300 Lot Number 130140, 130332, 134299; Part Number 10706-200 Lot Number 128522, 129567, 129781, 129891, 130741; Part Number 10707-200 Lot Number 128815, 129782, 129783, 129784, 130182, 131410, 132880. |
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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-0883-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.