Food, drugs, devices › Zimmer Manufacturing B.V.
Device recall: Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and
FDA enforcement event 68547 is a device recall by Zimmer Manufacturing B.V. of Mercedita, PR, initiated 12 Jun 2014 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 24 Jun 2015. Initiation: voluntary: firm initiated. Zimmer Manufacturing B.V. 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
Zimmer Manufacturing B.V., Mercedita, PR.
Reason for recall
"Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14."
Distribution
"Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2032-2014 | Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process. | 496 | Class II | Terminated | 16 Jul 2014 |
Context
Other enforcement events for Zimmer Manufacturing B.V.
All 8 events for Zimmer Manufacturing B.V.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14."
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 - USA (nationwide) and the countries of India, Japan, China, Australia and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 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.