AS COLUMBUS CR/PS TIB — Class II medical device recall Z-1481-2020
Terminated recall by Aesculap Implant Systems LLC, reported 2020-03-25, distributed nationwide. Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the
| Recall number | Z-1481-2020 |
|---|---|
| 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 | 2020-01-21 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BG, BR, CH, CL, CN, CO, CR, CZ, DE, DZ, EC, EE, ES, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LT, LV, MX, MY, NG, NL, PL, PT, PY, SA, SG, SV, TH, TR, UA, ZA |
| Lot numbers | 52533610 |
| Model numbers | NN058Z, NN070Z, NN071Z, NN072Z, NN073Z, NN074Z, NN075Z, NN076Z, NN077Z, NN078Z, NN079Z, NN470Z, NN471Z, NN472Z, NN473Z, NN474Z, NN475Z, NN476Z, NN477Z, NN478Z, NN479Z |
Product
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.
Reason for recall
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
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-1481-2020. 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.