SKAFFOLD FLOW — Class II medical device recall Z-2627-2020
Terminated recall by Skeletal Kinetics, Llc, reported 2020-07-22, distributed nationwide. Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use ma
| Recall number | Z-2627-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Skeletal Kinetics, Llc, Addison, TX, United States |
| Recall initiated | 2020-04-06 |
| Classified | 2020-07-15 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2021-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, ZA |
| Quantity | 29 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00813845020887 |
| Lot numbers | 1137058, 17020101 |
Product
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Reason for recall
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
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-2627-2020. 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.