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Terminated

Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.

FDA Recall Z-1539-2012 · Posted 2012-05-11

Recalling FirmMitaka USA, Inc.
Recall StatusTerminated
Product CodeGWG
Date Initiated2009-02-27
Date Terminated2012-05-22
Product Quantity18 units (3 internationally and 15 within the U.S.)

Reason for Recall

Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.

Firm Action

Mitaka USA sent a letter dated to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included instructions for returning the product. Contact the Customer Support Department at 800-421-0837, ext. 7577 for questions regarding this notice.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984355POINT SETTERMitaka USA, Inc. · 1999-04-01

Official Source

View FDA Recall →

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

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