ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0 — Class II medical device recall Z-0619-2018
Terminated recall by Aesculap Implant Systems LLC, reported 2018-02-21, distributed in NM, OH, TX, WV. ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
| Recall number | Z-0619-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2019-09-20 |
| Distributed | NM, OH, TX, WV |
| Quantity | 10,984 |
| Model numbers | GP111R, GP112R, GP113R, GP113TC, GP114R, GP115R, GP116R, GP117R, GP118R, GP119TC, GP120R, GP121R, GP122R, GP123R, GP124R, GP124TC, GP125R, GP126R, GP126TC, GP127R, GP128R, GP128TC, GP129R, GP129TC, GP133R and 141 more |
Product
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC D2.0 ELAN 4 1-RING ROSEN BURR D2.3 ELAN 4 1-RING ROSEN BURR+ D2.3 ELAN 4 1-RING ROSEN BURR D2.7 ELAN 4 1-RING ROSEN BURR+ D2.7 ELAN 4 1-RING ROSEN BURR D3.0 ELAN 4 1-RING ROSEN BURR TC D3.0 ELAN 4 1-RING ROSEN BURR D3.5
Reason for recall
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
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-0619-2018. 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.