NUVASIVE SPECIALIZED ORTHOPEDICS — Class II medical device recall Z-0069-2021
Ongoing recall by Nuvasive Specialized Orthopedics Inc, reported 2020-10-14, distributed nationwide. During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociat
| Recall number | Z-0069-2021 |
|---|---|
| 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 | 2020-07-24 |
| Classified | 2020-10-07 |
| Reported by FDA | 2020-10-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, DE, DK, ES, FR, GB, IL, LU, NL |
| Quantity | 41 units |
| Serial numbers | 9011815AAA, 9012506AAA, 9013007AAA, 9020607AAA, 9020608AAA, 9020609AAA, 9020809AAA, 9020810AAA, 9021222AAA, 9021223AAA, 9021224AAA, 9021510AAA, 9021512AAA, 9021513AAA, 9021514AAA, 9021913AAA, 9021914AAA, 9021915AAA, 9022225AAA, 9022226AAA, 9022227AAA, 9022813AAA, 9022815AAA, 9022816AAA, 9030706AAA and 36 more |
| Model numbers | PA1159-10B380-7, PA1159-10B400-7, PA1159-10D380-7, PA1159-10D400-7, PA1159-10SJ360-7, PA1159-10SJ380-7, PA1159-10SJ400-7, PA1159-70SJ300-7, PA1159-80SJ320-7, PA1159-80X320-7, PA1159-90SJ340-7, PA1160-10B360-7, PA1160-10B380-7, PA1160-10B400-7, PA1160-10D360-7, PA1160-10D380-7, PA1160-10D400-7, PA1160-10SJ360-7, PA1160-10SJ380-7, PA1160-10SJ400-7, PA1160-10X360-7, PA1160-10X380-7, PA1160-10X400-7, PA1160-60SJ280-6, PA1160-70SJ300-7 and 10 more |
Product
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).
Reason for recall
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
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-0069-2021. 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.