Cranio/Sculpt C — Class II medical device recall Z-2054-2020
Terminated recall by Skeletal Kinetics, Llc, reported 2020-05-27, distributed nationwide. Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not
| Recall number | Z-2054-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Skeletal Kinetics, Llc, Addison, TX, United States |
| Recall initiated | 2020-04-03 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2025-01-30 |
| Distributed | Nationwide (US) |
| Quantity | 125 units |
| UPC / GTIN / UDI-DI | 00813845021129 |
| Lot numbers | 1129289 |
Product
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2. CRANIO/SCULPT C may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
Reason for recall
Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
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-2054-2020. 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.