CLASS II Device recall · Reported 7 Nov 2012 · FDA Enforcement Report
Extremity Components: Prothese A Expansion Complete D=6 LG recalled
Wright Medical Technology is recalling Extremity Components: Prothese A Expansion Complete D=6 LG, distributed nationwide in the US. The recall was initiated on 5 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0185-2013
- FDA event ID
- 63338
- Recalling firm
- Wright Medical Technology, Arlington, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2012
- FDA classified
- 31 Oct 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 5 Sep 2012 | Recall initiated by company | |
| 31 Oct 2012 | Classified by FDA | +56 days |
| 7 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Orthopaedic
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
Questions about this recall
Is Extremity Components: Prothese A Expansion Complete D=6 LG recalled?
Yes. Wright Medical Technology recalled Extremity Components: Prothese A Expansion Complete D=6 LG on 5 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0185-2013.
Why was it recalled?
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Which lots are affected?
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 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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