Recall Z-0823-2017— Stanmore Implants Worldwide Ltd.
Class II · Terminated
Class II FDA medical device recall by Stanmore Implants Worldwide Ltd., initiated 2016-12-07, terminated 2017-07-17. It names one FDA 510(k) clearance: K120992. Product: Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone. Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem..
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-07
- Terminated
- 2017-07-17
- Firm location
- Borehamwood, N/A, United Kingdom
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
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Reason for recall
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Data sourced from openFDA. This site is unofficial and independent of the FDA.