FDA Device recall Z-2157-2016
4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for frac…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for frac… by Synthes Usa Products, citing labeling does not match the cleared indications for use in the United States and Canada.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2157-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
Reason
Labeling does not match the cleared indications for use in the United States and Canada.
Identifiers
| code_info | Many affected part numbers |
|---|
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-2157-2016%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.