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Terminated

EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

FDA Recall Z-1674-2015 · Posted 2015-05-26

Recalling FirmDePuy Spine, Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2015-04-21
Date Terminated2018-10-03
Product Quantity183 devices

Reason for Recall

Device does not mate as intended.

Firm Action

Consignees were notified of the recall via letter sent by overnight shipment for delivery on April 23, 2015. The letter instructs distributors and customers to review their inventory and return any products with the listed lot number.

Root Cause

Process design

Distribution Pattern

US: PA and OUS: SE, BE, IT, PT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMDepuy Spine, Inc. · 2012-06-14K101070EXPEDIUM SPINE SYSTEMMedos International SARL · 2010-08-31

Official Source

View FDA Recall →

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

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