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Terminated

RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas

FDA Recall Z-0809-04 · Posted 2004-07-20

Recalling FirmCenterpulse Orthopedics, Inc
Recall StatusTerminated
Product CodeLZO
Date Initiated2003-09-30
Date Terminated2004-11-04
Product Quantity145 units

Reason for Recall

Compalints of acetabular shell disassociating with the bone.

Firm Action

The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all inventory.

Root Cause

Other

Distribution Pattern

Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022985ASCENDENT ACETABULAR SYSTEMSulzer Orthopedics, Inc. · 2002-12-05

Official Source

View FDA Recall →

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

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