KRD1 PedFuse Rods — Class II medical device recall Z-1737-2013
Terminated recall by SpineFrontier, Inc., reported 2013-07-24, distributed nationwide. One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 d
| Recall number | Z-1737-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2011-12-30 |
| Classified | 2013-07-16 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2014-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 2 rods |
| Lot numbers | 002876-007R |
| Model numbers | IM80100-13 |
Product
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
Reason for recall
One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
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-1737-2013. 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.