Food, drugs, devices › Integra York PA, Inc
Device recall: Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Integra York PA, Inc (York, PA) initiated this device recall on 11 Mar 2016; FDA lists 1 product record under event 74079, 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 17 Apr 2017. Initiation: voluntary: firm initiated. Integra York PA, Inc has 3 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
Integra York PA, Inc, York, PA.
Reason for recall
"One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle."
Distribution
"Worldwide distribution. US nationwide, Mexico, and Korea."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1841-2016 | Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument. | 678 Chisel Blade Holders | Class II | Terminated | 8 Jun 2016 |
Context
Other enforcement events for Integra York PA, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Oct 2016 | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-us | Device | Class II | 2 |
| 30 Jul 2014 | Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, | Device | Class II | 1 |
All 3 events for Integra York PA, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle."
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: "Worldwide distribution. US nationwide, Mexico, and Korea."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Apr 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.