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FDA Medical Device Recalls (openFDA)

Applied Medical Resources Corp: Applied Blunt Tip Trocar Models C0717 and C0718

Recall number
Z-0009-05
Recalling firm
Applied Medical Resources Corp
Product
Applied Blunt Tip Trocar Models C0717 and C0718
Status
Terminated
Initiated
2004-09-17
Posted
2004-10-05
Terminated
2005-08-05
Reason
Inadequate trocar tip assembly that might yeild parts to patients.
Root cause
Other
Action
Initiated recall by letter on 9/16/2004 via Fedex/UPS. Follow-up to nonresponders in 30 days.
Quantity
1025
Distribution
Nationwide. Ireland.
Lot, serial or model codes
Trocars are assembled into procedure kits. Trocars have thier own serial number but the kit lots are relevant and include:  45036301001 to 45036301007 containing 1 each of lot 126803 = 71 each; 45208001001 to 452084001008 containing 1 each of lot 127322=8 each; 452451005001 to 452451005003 containing 1 each of lot 127322=3 each; 453029001001 to 453029001017 containing 1 each of lot 127322 = 17 each; 453715004002 containing 1 each of lot 126803 = 1 each; 454116005001 to 454116005002 containing 1 each of lot 127322 = 2; 454608003001 to 454608003006 containing 1 each of lot 172528 = 6 each.
510(k) numbers
["K923636"]
PMA numbers
not on file
Product code
KXN
Firm FEI
2027111
Firm city
Rancho Santa Margarita
Firm state
CA
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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