—#126952

Product

ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.

FDA product code: HTT — Burr, Orthopedic
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K011444
Affected lot / code info: Lot/Set/Serial: G323081803.

Why it was recalled

Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email customer.support@synthes.com.. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661. 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: Nationwide Distribution including FL, TX, NC, IL, CO, and PA.

Timeline

Recall initiated: 2014-01-08
Posted by FDA: 2014-05-09
Terminated: 2015-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126952. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.