FDA Medical Device Recalls (openFDA)
Synthes USA (HQ), Inc.: Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
- Recall number
- Z-0825-2010
- Recalling firm
- Synthes USA (HQ), Inc.
- Product
- Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
- Status
- Terminated
- Initiated
- 2010-01-06
- Posted
- 2010-02-24
- Terminated
- 2010-10-06
- Reason
- There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.
- Root cause
- Other
- Action
- An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.
- Quantity
- 187 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K021458"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- 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