Data Foundry

Medical device recalls 2019

2 — Class II medical device recall Z-0531-2020

Terminated recall by Zimmer Biomet, Inc., reported 2019-12-04, distributed nationwide. Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Recall numberZ-0531-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Biomet, Inc., Warsaw, IN, United States
Recall initiated2019-08-21
Classified2019-11-22
Reported by FDA2019-12-04
Terminated2021-07-21
DistributedNationwide (US)
Countries outside the USAR, AU, BR, CA, CL, CO, CR, EC, IN, IT, JP, KR, MX, MY, NL, NZ, PA, SG, SV, TH, TT, TW, VE
Quantity2,708
Reason classesmicrobial contamination, sterility
UPC / GTIN / UDI-DI00887868029448
Lot numbers036290, 036320, 036330, 039330, 039340, 039350, 039360, 039370, 039380, 039390, 039400, 039410, 039420, 039430, 039440, 039450, 039460, 039470, 062690, 062720, 062740, 062760, 062950, 062960, 062970, 062980, 113340, 114600, 158510, 158520, 158530, 164579, 164582, 164586, 164587, 167450, 204150, 204160, 204180, 204190 and 63 more
Model numbers281017006

Product

2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

Reason for recall

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

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-0531-2020. 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.