GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.
FDA Recall Z-2138-2008 · Posted 2008-08-02
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Recalling FirmSynovis Micro Companies Alliance Inc
Recall StatusTerminated
Product CodeMVR
Date Initiated2008-05-14
Date Terminated2010-04-09
Product Quantity3,812 units
Reason for Recall
Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
Firm Action
Urgent Recall Notification was sent via Fed Ex on May 15, 2008 to 432 hospitals. The letters were addressed to the attention of the Risk Manager. The recall notification instructed the hospital to immediately discontinue use, examine their inventory and, if found, to remove the product and quarantine it for return. A second notification was sent on July 21, 2008 to non-responding consignees.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution --- including USA and countries of Canada, Japan, UAE, Korea, South Africa, Australia, Taiwan, Norway, Netherlands, Sweden, Greece, Norway, Turkey, Portugal, Taiwan, Denmark, Italy, Germany, Japan, Spain, Austria, and Great Britain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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