Food, drugs, devices › Flower Orthopedics Corporation
Device recall: Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ra
FDA enforcement event 89092 is a device recall by Flower Orthopedics Corporation of Horsham, PA, initiated 2 Nov 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 12 Oct 2023. Initiation: voluntary: firm initiated. Flower Orthopedics Corporation has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Flower Orthopedics Corporation, Horsham, PA.
Reason for recall
"Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available"
Distribution
"US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0448-2022 | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1 | 48 units | Class II | Terminated | 12 Jan 2022 |
Context
Other enforcement events for Flower Orthopedics Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Aug 2023 | Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary | Device | Class II | 1 |
| 3 Sep 2021 | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 | Device | Class II | 1 |
| 1 Sep 2021 | Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been c | Device | Class II | 4 |
| 15 Apr 2021 | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to inse | Device | Class II | 1 |
| 8 Jul 2020 | Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixati | Device | Class II | 6 |
| 22 Dec 2016 | Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. | Device | Class II | 1 |
| 16 Feb 2015 | Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking P | Device | Class II | 1 |
All 8 events for Flower Orthopedics Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.