Data Foundry

Medical device recalls 2012

Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal… — Class II medical device recall Z-1895-2012

Terminated recall by Zimmer, Inc., reported 2012-07-04, distributed nationwide. Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Cata

Recall numberZ-1895-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer, Inc., Warsaw, IN, United States
Recall initiated2012-05-12
Classified2012-06-27
Reported by FDA2012-07-04
Terminated2013-09-12
DistributedNationwide (US)
Quantity87 units
Reason classeslabeling
Lot numbers62071190
Model numbers47-4307-031-00

Product

Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.

Reason for recall

Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190.

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-1895-2012. 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.