FDA Medical Device Recalls (openFDA)
Synthes USA: SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
- Recall number
- Z-0460-2012
- Recalling firm
- Synthes USA
- Product
- SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
- Status
- Terminated
- Initiated
- 2011-09-29
- Posted
- 2012-01-11
- Terminated
- 2014-12-18
- Reason
- A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
- Root cause
- Labeling Change Control
- Action
- All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident.
- Quantity
- 131 units
- Distribution
- Synthes USA sent a "NOTICE: MISSING SHIPMENT-NORIAN SRS" letter dated September 29, 2011 to all accounts with a history of purchasing the product in the past two years. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory to verify they have not received the affected product. Call 1-800-620-7025 ext. 5450 for questions concerning this notice.
- Lot, serial or model codes
- Part Number SRS-005-FSP, Lot number N001101
- 510(k) numbers
- ["K060408"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3008812560
- 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
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