Food, drugs, devices › Zimmer, Inc.
Device recall: Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15.
FDA enforcement event 65513 is a device recall by Zimmer, Inc. of Warsaw, IN, initiated 19 Jun 2013 and classified Class II, with 5 product records.
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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 16 Jun 2015. Initiation: voluntary: firm initiated. Zimmer, Inc. has 108 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, Inc., Warsaw, IN.
Reason for recall
"Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product."
Distribution
"Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2090-2013 | Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant. | 85, 794 units in total | Class II | Terminated | 4 Sep 2013 |
| Z-2091-2013 | Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant. | 85, 794 units in total | Class II | Terminated | 4 Sep 2013 |
| Z-2092-2013 | VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant. | 85, 794 units in total | Class II | Terminated | 4 Sep 2013 |
| Z-2093-2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. orthopedic implant. | 85, 794 units in total | Class II | Terminated | 4 Sep 2013 |
| Z-2094-2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant. | 85, 794 units in total | Class II | Terminated | 4 Sep 2013 |
Context
Other enforcement events for Zimmer, Inc.
All 108 events for Zimmer, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product."
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 (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jun 2015. "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.