SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiot
FDA device recall Z-1246-2015 · posted 2015-03-05 · Terminated
Recall details
- Recalling firm
- DePuy Orthopaedics, Inc.
- Reason for recall
- One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
- Action taken
- DePuy Orthopaedics, Inc. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). Consignees were instructed to discontinue use of the affected lot of bone cement immediately and destroy according to the consignees hazardous materials protocol or return if Certified Dangerous Goods Shipper, holding an International Air Transport Association (IATA) certification. Customers were instructed to call 574-371-4917 (M-F; 8 am 5 pm EST). For questions regarding this recall call 574-371-4577.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MBB
- Quantity affected
- 1267
- Distribution
- Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.
- Date initiated
- 2015-02-11
- Date posted
- 2015-03-05
- Date terminated
- 2015-05-19
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMARTSET GHV GENTAMICIN BONE CEMENT (K033563) | DePuy Orthopaedics, Inc. | 2004-02-05 |