Precice Bone Transport — Class II medical device recall Z-1324-2021
Ongoing recall by Nuvasive Specialized Orthopedics Inc, reported 2021-04-07, distributed nationwide. Due to complaints of adverse events potentially related to biological safety. The complaints included report o
| Recall number | Z-1324-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nuvasive Specialized Orthopedics Inc, Aliso Viejo, CA, United States |
| Recall initiated | 2021-02-12 |
| Classified | 2021-03-30 |
| Reported by FDA | 2021-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, CA, CH, CL, CO, CY, DE, DK, ES, FI, FR, GR, HK, IL, IT, NL, PT, SA, SE, SI, SK, TR, ZA |
| Quantity | 226 units |
| UPC / GTIN / UDI-DI | 00887517976109, 00887517976116, 00887517976123, 00887517976130, 00887517976147, 00887517976154, 00887517976161, 00887517976178, 00887517976185, 00887517976192, 00887517976208, 00887517976215, 00887517976222, 00887517976239, 00887517976246, 00887517976253, 00887517976260, 00887517976277, 00887517976284, 00887517976291, 00887517976307, 00887517976314, 00887517976321, 00887517976338, 00887517976345 and 475 more |
Product
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Reason for recall
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
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-1324-2021. 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.