Synthes 2 — Class II medical device recall Z-0124-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-10-21, distributed in AL, AZ, CA, FL, GA, IL, IN, KY…. The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorr
| Recall number | Z-0124-2016 |
|---|---|
| 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 | 2015-09-28 |
| Classified | 2015-10-15 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2016-12-06 |
| Distributed | AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, NC, ND, NJ, OH, PA, TN, VA, WV |
| Quantity | 36 |
| Reason classes | labeling |
| Lot numbers | 2.7MM/3.5MM |
| Model numbers | 2.7MM/3.5MM |
Product
Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, " Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. " Olecranon and proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
Reason for recall
The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S
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-0124-2016. 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.