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Open, Classified

Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

FDA Recall Z-0843-2024 · Posted 2024-01-29

Recalling FirmFX SHOULDER
Recall StatusOpen, Classified
Product CodePHX
Date Initiated2023-08-08
Product Quantity4

Reason for Recall

Centered glenosphere box may contain an eccentric glenosphere.

Firm Action

On 8/8/23, the firm telephoned the customer and informed them of the recall. The customer was asked to quarantine the device, which was subsequently collected by the firm.

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide distribution in the state of NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc. · 2020-07-15

Official Source

View FDA Recall →

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

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