COLUMBUS CRA/PSA TIB — Class II medical device recall Z-1480-2020

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-1480-2020`
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	`NN469K`, `NN470K`, `NN471K`, `NN472K`, `NN473K`, `NN474K`, `NN475K`, `NN476K`, `NN477K`, `NN478K`, `NN479K`

Product

COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K 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-1480-2020. 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.