Atlas FDA

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

FDA device recall Z-0013-05 · posted 2004-10-08 · Terminated

Recall details

Recalling firm
Biomet, Inc.
Reason for recall
Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
Action taken
Consignees were notified by recall letter dated July 7, 2004 and sent via fax.
Root cause
Other
Status
Terminated
Product code
HTY
Quantity affected
37
Distribution
Colorado, Mississippi, Missouri, Montana, New York, Ohio, Pennsylvania, Texas and Wisconsin.
Date initiated
2004-07-07
Date posted
2004-10-08
Date terminated
2004-10-07
Location
Warsaw, IN

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Related 510(k) clearances

RecordFirmDate
LACTOSORB BONE PIN (K990291)Biomet, Inc.1999-03-23