Food, drugs, devices › Flower Orthopedics Corporation
Device recall: Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Flower Orthopedics Corporation (Horsham, PA) initiated this device recall on 22 Dec 2016; FDA lists 1 product record under event 76156, classified Class II.
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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 27 Nov 2017. 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
"The product is being recalled due to incidence and reports of the product breaking during surgery."
Distribution
"Distributed throughout the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1113-2017 | Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. | N/A | Class II | Terminated | 8 Feb 2017 |
Context
Other enforcement events for Flower Orthopedics Corporation
All 8 events for Flower Orthopedics Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The product is being recalled due to incidence and reports of the product breaking during surgery."
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: "Distributed throughout the United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Nov 2017. "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.