Recall Z-2390-2020— Medtronic Sofamor Danek USA Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2020-04-24, terminated 2021-03-31. It names 3 FDA 510(k) clearances: K041454, K010246, K981251. Product: Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.. Reason: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-24
- Terminated
- 2021-03-31
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
3 on FDA's record- K041454 — KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
- K010246 — KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
- K981251 — KYPHON INFLATABLE BONE TAMP
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
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Reason for recall
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.