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Terminated

PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument

FDA Recall Z-1696-2015 · Posted 2015-05-29

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2015-04-30
Date Terminated2016-03-15
Product Quantity1,689

Reason for Recall

Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.

Firm Action

On 4/30/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications dated April 30, 2015 were sent to the affected distributors, hospital Risk Managers, and surgeons via courier; all distributors were also notified via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.

Official Source

View FDA Recall →

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

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