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Terminated

Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400

FDA Recall Z-1208-2015 · Posted 2015-02-24

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKWS
Date Initiated2015-01-07
Date Terminated2015-10-22
Product Quantity11- 6 consumed, 5 with distributors

Reason for Recall

The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

Firm Action

Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root Cause

Process control

Distribution Pattern

Domestic: AL, FL, NY, TX Foreign: None

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120121COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATEBiomet, Inc. · 2012-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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