Device recall: Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE…
Class II FDA enforcement event 63338. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Class II, in the words of FDA
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
Wright Medical Technology Inc started this device recall on 5 Sep 2012. The firm address in the FDA record is in Arlington, TN. FDA put the recall in Class II. FDA event 63338 has 3 product records. The first FDA enforcement report date is 7 Nov 2012. The record gives the status Terminated, with the termination date 7 Jan 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania,…
Recalling firm
Wright Medical Technology Inc, Arlington, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0183-2013 | Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS,… | 31,566 units | Class II | Terminated | 7 Nov 2012 |
| Z-0184-2013 | Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080,… | 729 units | Class II | Terminated | 7 Nov 2012 |
| Z-0185-2013 | Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG… | 840 units | Class II | Terminated | 7 Nov 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 3Median of the firm: 2
- Events of the firm on the register
- 26
Other events of the firm
Official channels
- FDA enforcement report Z-0183-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 63338. https://recallregister.com/fda/ii/63338/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania,…
- What quantity of product is in FDA event 63338?
- The event has 3 product records. The first record gives this quantity:
31,566 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.