Food, drugs, devices › Zimmer Biomet, Inc.
Device recall: Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The re
Zimmer Biomet, Inc. (Warsaw, IN) initiated this device recall on 3 Apr 2018; FDA lists 1 product record under event 79692, 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 2 Jul 2018. Initiation: voluntary: firm initiated. Zimmer Biomet, Inc. has 144 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
Zimmer Biomet, Inc., Warsaw, IN.
Reason for recall
"There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar."
Distribution
"The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1522-2018 | Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee. | 16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was… | Class II | Terminated | 2 May 2018 |
Context
Other enforcement events for Zimmer Biomet, Inc.
All 144 events for Zimmer Biomet, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar."
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: "The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Jul 2018. "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.