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Terminated

Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801

FDA Recall Z-1675-2016 · Posted 2016-05-16

Recalling FirmZimmer Manufacturing B.V.
Recall StatusTerminated
Product CodeHWC
Date Initiated2016-05-04
Date Terminated2017-07-05
Product Quantity200

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.

K082527ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWSZimmer, Inc. · 2008-12-18

Official Source

View FDA Recall →

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

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