Piccolo Composite Tibia and Femoral Nailing Systems — Class II medical device recall Z-1991-2016
Terminated recall by CarboFix Orthopedics, Ltd., reported 2016-06-22, distributed in AL, AZ, CA, CO, DC, FL, GA, IN…. Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and
| Recall number | Z-1991-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CarboFix Orthopedics, Ltd., Herzliya, Israel |
| Recall initiated | 2016-05-10 |
| Classified | 2016-06-14 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-01-27 |
| Distributed | AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA |
| Quantity | 638 |
| Reason classes | sterility |
| Lot numbers | QTN02700, QTN02785A, QTN04161A, QTN43801, QTN43801A, QTN43801B, QTN61401, QTN61402, QTN61402A, QTN83201B, QTN83201C, QTN90712 |
| Model numbers | PFT912250 |
Product
Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Reason for recall
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
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-1991-2016. 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.