Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixati
FDA device recall Z-0941-2013 · posted 2013-03-11 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
- Action taken
- Synthes sent an Urgent Notice: Medical Device Recall letter dated January 11, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product(s), remove them from inventory and return them to Synthes. For questions call 610-719-5450 or email FieldAction@synthes.com
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 136
- Distribution
- USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
- Date initiated
- 2013-01-11
- Date posted
- 2013-03-11
- Date terminated
- 2015-08-31
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL (K082650) | Synthes (Usa) | 2008-11-18 |