Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0013-05

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

Zimmer GmbH / initiated 2004-07-07 / Terminated / root cause: labeling and UDI

Biomet, Inc. began a recall of Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205 on . The reason FDA records is "Mislabeled as to size; 1.55 mm pins are labeled as 2mm". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0013-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Product code
HTY Pin, Fixation, Smooth
Reason for recall
Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Consignees were notified by recall letter dated July 7, 2004 and sent via fax.
Quantity in commerce
37
Distribution
Colorado, Mississippi, Missouri, Montana, New York, Ohio, Pennsylvania, Texas and Wisconsin.
Product codes and lots
Lot 439010 Exp. 2006-11.