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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0013-05
Recalling firm
Biomet, Inc.
Product
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Status
Terminated
Initiated
2004-07-07
Posted
2004-10-08
Terminated
2004-10-07
Reason
Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
Root cause
Other
Action
Consignees were notified by recall letter dated July 7, 2004 and sent via fax.
Quantity
37
Distribution
Colorado, Mississippi, Missouri, Montana, New York, Ohio, Pennsylvania, Texas and Wisconsin.
Lot, serial or model codes
Lot 439010 Exp. 2006-11.
510(k) numbers
["K990291"]
PMA numbers
not on file
Product code
HTY
Firm FEI
1825034
Firm city
Warsaw
Firm state
IN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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