FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics: Gamma Drill 5.5x300mm
- Recall number
- Z-0579-03
- Recalling firm
- Stryker Howmedica Osteonics
- Product
- Gamma Drill 5.5x300mm
- Status
- Terminated
- Initiated
- 2003-01-20
- Posted
- 2003-02-26
- Terminated
- 2003-05-06
- Reason
- Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Root cause
- Other
- Action
- Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.
- Quantity
- 5062
- Distribution
- Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
- Lot, serial or model codes
- 1214-5300S -- Gamma Drill 5.5x300mm -- K400056; K412682; K423453; K451275; K467231; K469197; K494341; K494342; K508650; K516457; K526734; K533284; K542636; K548132; K553788; K553789; K562650; K562654; K573121; K573122; K579936; K579937; K579938; K619518; K622108; K622109; K637404; K641097; K653378; K665203; K665204; K665205; K678519; K679127; K713867; K713868; K714918; K714919; K714920; K714921; K714922; K714923; K714924; K714925; K714926; K717459; K717462; K721328; K724574; K732012; K732013; K733474; K748814; K748817; K753097; K753098; K774660; K775180; K784772; K784774; K784775; K821925; K829527; K829529; K834976; K957002.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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