Data Foundry

Medical device recalls 2020

RINGLOC BIPOLAR Hip System Bi Polar Locking Ring — Class II medical device recall Z-0628-2021

Terminated recall by Biomet, Inc., reported 2020-12-23, distributed nationwide. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packa

Recall numberZ-0628-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomet, Inc., Warsaw, IN, United States
Recall initiated2020-11-25
Classified2020-12-17
Reported by FDA2020-12-23
Terminated2024-05-08
DistributedNationwide (US)
Countries outside the USAR, AU, BR, CA, CL, CN, CR, HK, IN, JP, KR, MY, NZ, SG, TW
Quantity7,428
Reason classessterility, packaging
Lot numbers173500
Model numbers11-165304

Product

RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.

Reason for recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

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-0628-2021. 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.