Recall Z-1759-2018
Synthes (USA) Products LLC · initiated April 2, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Codes / lots: Lot numbers: T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728 T151369, T151488, T152808, T152809, T153884, T155649, T958061
Reason for recall
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
FDA-determined cause: Under Investigation by firm
Action taken
On April 2, 2018 Synthes (USA) LLC mailed an Urgent Product Recall notification letter to affected customers. Customers were instructed to: Review current inventory to identify and quarantine all affected products; Complete the Verification section of the Return Receipt form; Return affected product; Forward the notification to anyone in your facility that needs to be informed; If affected products have been forwarded to another facility, contact that facility to arrange return; Keep a copy of the notification. Customers with questions may call (610)719-5450 or contact your Depuy Synthese Sales Consultant.
Details
- Recall number
- Z-1759-2018
- Initiated
- April 2, 2018
- Terminated
- October 16, 2019
- Product code
- GAD – Retractor
- Quantity
- 196
- Distribution
- US Nationwide and Canada
- Recalling firm
- Synthes (USA) Products LLC, West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1758-2018 Class II | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores… | 04/02/2018Terminated |