FDA Medical Device Recalls (openFDA)
Southmedic, Inc.: Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.
- Recall number
- Z-0990-2011
- Recalling firm
- Southmedic, Inc.
- Product
- Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.
- Status
- Terminated
- Initiated
- 2010-09-03
- Posted
- 2011-01-31
- Terminated
- 2011-05-18
- Reason
- Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
- Root cause
- Packaging process control
- Action
- On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.
- Quantity
- 1330 cases all products
- Distribution
- Worldwide Distribution -- USA, including states of TX, MO, NJ, LA, IL, NY, KY, PA, VA, WA, CA, MA, MD, IN, NV, TN, NC, AZ, IA, WI, UT, NE, GA, FL, MN, ME, OH, SD, and KS and countries of Australia and Canada.
- Lot, serial or model codes
- Lot numbers: 070910, 081610, 90110, 91410, and 93010.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDX
- Firm FEI
- 3001717360
- Firm city
- Barrie Canada
- Firm state
- Ontario
- 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