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Terminated

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

FDA Recall Z-0013-05 · Posted 2004-10-08

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHTY
Date Initiated2004-07-07
Date Terminated2004-10-07
Product Quantity37

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990291LACTOSORB BONE PINBiomet, Inc. · 1999-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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