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FDA Medical Device Recalls (openFDA)

Stryker Instruments Div. of Stryker Corporation: Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.

Recall number
Z-0034-06
Recalling firm
Stryker Instruments Div. of Stryker Corporation
Product
Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
Status
Terminated
Initiated
2005-07-22
Posted
2005-10-12
Terminated
2006-02-15
Reason
The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
Root cause
Other
Action
Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.
Quantity
473
Distribution
Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.
Lot, serial or model codes
Serial numbers 0428702183 through 0518008193.
510(k) numbers
["K844214"]
PMA numbers
not on file
Product code
LXC
Firm FEI
1811755
Firm city
Kalamazoo
Firm state
MI
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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