FDA Device recall Z-0639-2017
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile by Synthes Usa Products, citing the peel pouches for the affected reaming rods and extraction hooks are delaminating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0639-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-03 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
Reason
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Identifiers
| code_info | Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H0430…Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H043058; H043551; H043564; H054931; H054932; H054933; H056192; H056193; H056194; H058374; H058375; H058376; H058377; H058378; H059426; H059427; H059428; H067852; H067853; H069071; H069073; H077277; H077452; H077704; H086318; H086319; H087018; H089848; H089849; H089850; H090012; H090013; H090014; H090745; H099607; H099608; H099610; H099611; H115889; H115890; H115891; H115892; H122535; H122998; H123001; H123002; H123970; H123975; H135276; H135277; H135278; H141083; H141085. |
|---|
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-0639-2017%22
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