Recall Z-2058-2013— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2012-11-02, terminated 2016-09-27. It names 5 FDA 510(k) clearances: K040336, K040762, K033618 and 2 more. Product: Synthes Trauma Nail System. The devices are indication for bone fixation.. Reason: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-02
- Terminated
- 2016-09-27
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K040336 — SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
- K040762 — SYNTHES (USA) TIBIAL NAIL SYSTEM EX
- K033618 — SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
- K033071 — SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
- K011857 — SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Synthes Trauma Nail System. The devices are indication for bone fixation.
Reason for recall
Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.