Recalls / —

—#33962

Product

Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.

FDA product code

HTY — Pin, Fixation, Smooth

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K990291

Affected lot / code info

Lot 439010 Exp. 2006-11.

Why it was recalled

Mislabeled as to size; 1.55 mm pins are labeled as 2mm.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by recall letter dated July 7, 2004 and sent via fax.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

Colorado, Mississippi, Missouri, Montana, New York, Ohio, Pennsylvania, Texas and Wisconsin.

Timeline

Recall initiated

2004-07-07

Posted by FDA

2004-10-08

Terminated

2004-10-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #33962. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.