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FDA Medical Device Recalls (openFDA)

Stryker Howmedica Osteonics: Trident Insert Impactor

Recall number
Z-0901-03
Recalling firm
Stryker Howmedica Osteonics
Product
Trident Insert Impactor
Status
Terminated
Initiated
2003-04-28
Posted
2003-05-29
Terminated
2003-11-12
Reason
The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
Root cause
Other
Action
Howmedica sent recall letters and acknowledgement forms via FedEx on April 29, 2003 with return receipt.
Quantity
1758
Distribution
The product has been distributed the Howmedica branches and sales reps, hospitals, and International Howmedica distributors located in Sweden, China, France, Netherlands, Germany, Spain, Australia, Japan, New Zealand, Switzerland, Portugal, England, Chile, and Brazil.
Lot, serial or model codes
Catalog Number: 2111-0000
510(k) numbers
not on file
PMA numbers
not on file
Product code
HWA
Firm FEI
3003070421
Firm city
Mahwah
Firm state
NJ
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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