SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
FDA Recall Z-0460-2012 · Posted 2012-01-11
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Recalling FirmSynthes USA
Recall StatusTerminated
Product CodeMQV
Date Initiated2011-09-29
Date Terminated2014-12-18
Product Quantity131 units
Reason for Recall
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.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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