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Terminated

Trabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile, Zimmer Inc., Parsippany, NJ.

FDA Recall Z-2217-2010 · Posted 2010-08-12

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2010-04-06
Date Terminated2011-10-21
Product Quantity1,972 all products

Reason for Recall

The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.

Firm Action

The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.

Root Cause

Packaging

Distribution Pattern

US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061067TRABECULAR METAL ACETABULAR AUGMENTSZimmer Trabecular · 2006-05-25

Official Source

View FDA Recall →

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

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