Synthes Periarticular Insertion Handle for 4 — Class II medical device recall Z-0024-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-10-14. Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.
| Recall number | Z-0024-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-10-05 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-07-15 |
| Quantity | 172 |
| Lot numbers | 1780074, 1780076, 1789751, 1789754, 1797331, 1802318, 1802319, 1810704, 1810705, 1810706, 1810707, 1828749, 1829294, 1829296, 1829300, 1879604, 5704446 |
| Model numbers | 03.120.001, 03.120.002, 03.120.004, 03.120.005 |
Product
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Reason for recall
Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0024-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.