Columbus R/PS TIB — Class II medical device recall Z-1478-2020
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-1478-2020 |
|---|---|
| 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 |
| Quantity | 24,010 |
| Lot numbers | 52533610 |
| Model numbers | NN058K, NN070K, NN071K, NN072K, NN073K, NN074K, NN075K, NN076K, NN077K, NN078K, NN079K |
Product
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K 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-1478-2020. 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.