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Recall Observatory FDA recall evidence

Device product

ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1875-2014

November 28, 2012

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 64247
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-1875-2014

Official wording

Reason: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.

Code information: Part Numbers: 98-0006, 98-0009. Serial Numbers: 20030001, 20030002 20033501, 20033502.

Distribution pattern: Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.