Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF
FDA device recall Z-1807-2010 · posted 2010-06-16 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union.
- Action taken
- On April 14, 2010, Acumed began contacting consignees by telephone. On April 15, 2010, Acumed sent out the URGENT NOTICE: DEVICE RECALL Initial Notification letter and Recalled Product Status Form to their consignees. The letter describes the recall product as Ulnar Shorting Saw Blade-Hub Style S, Part no. 80-0499-S and Lot Codes. The Initial Notification letter instructs consignees to return the product back to Acumed immediately and notify their sub-accounts (customers) if products have been further distributed. The consignees also are asked to fill out and send back the Recalled Product Status Form . Customers should call the Customer Service at 1-888-627-9957 or e-mail to RecallNotification@acumed.net for any questions regarding the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 718 units
- Distribution
- Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada, Turkey, Ireland, Finland, Belgium, Australia, Germany, and Sweden.
- Date initiated
- 2010-04-14
- Date posted
- 2010-06-16
- Date terminated
- 2010-06-28
- Location
- Hillsboro, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONGRUENT BONE PLATE SYSTEM (K012655) | Acu Med, Inc. | 2001-11-07 |