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FDA Medical Device Recalls (openFDA)

Stryker Howmedica Osteonics Corp.: Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation.

Recall number
Z-1821-2009
Recalling firm
Stryker Howmedica Osteonics Corp.
Product
Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation.
Status
Terminated
Initiated
2009-06-18
Posted
2009-08-18
Terminated
2012-08-27
Reason
Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.
Root cause
Process control
Action
Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.
Quantity
13 total, (both products)
Distribution
Nationwide Distribution
Lot, serial or model codes
Lot # 29233201; Exp. 2/3/2014
510(k) numbers
["K872224"]
PMA numbers
not on file
Product code
KTT
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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