—#115666

Product

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

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052572
Affected lot / code info: Part Numbers: 98-0006, 98-0009. Serial Numbers: 20030001, 20030002 20033501, 20033502.

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

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. .

Timeline

Recall initiated: 2012-11-28
Posted by FDA: 2014-06-25
Terminated: 2014-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115666. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.