Recall Z-1526-2018— Stryker GmbH
Class II · Terminated
Class II FDA medical device recall by Stryker GmbH, initiated 2018-03-12, terminated 2020-05-21. It names one FDA 510(k) clearance: K113327. Product: Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.. Reason: The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling.
- Recalling firm
- Stryker GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-12
- Terminated
- 2020-05-21
- Firm location
- Selzach, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-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
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
Reason for recall
The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
Data sourced from openFDA. This site is unofficial and independent of the FDA.