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Terminated

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FDA Recall Z-1683-2016 · Posted 2016-05-16

Recalling FirmZimmer Manufacturing B.V.
Recall StatusTerminated
Product CodeJDI
Date Initiated2016-05-04
Date Terminated2017-07-05
Product Quantity1199

Reason for Recall

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Firm Action

All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.

Root Cause

Packaging change control

Distribution Pattern

Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K840643HARRIS-GALANTE POROUS TOTAL HIP SYSZimmer, Inc. · 1984-04-17

Official Source

View FDA Recall →

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

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